7 Medical Scientist jobs in Australia
Medical Scientist - Cell Therapies - QLD
Brisbane, Queensland
Gilead Sciences, Inc.
Posted 11 days ago
Job Viewed
Job Description
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
**Job Description**
**Gilead Sciences** is a research-based biopharmaceutical company that discovers, develops, and commercialises innovative medicines in areas of unmet medical need. With each new drug discovery and investigational candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include liver viral illnesses, inflammatory diseases, and cancer.
Kite, a Gilead Company, is an organisation engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognise and kill tumours.
Gilead Sciences / Kite, Australia is seeking a knowledgeable and motivated professional capable of working effectively in a cross-functional team environment. The successful candidate will assume a full-time employment as a hybrid head office and field-based Medical Scientist, Kite in the Medical Affairs department and report to the Country Medical Lead, Kite Medical Affairs. This role is based in Queensland and will cover North of Newcastle through to Queensland. Be part of a growing team that values collaboration and fosters an inclusive working environment.
This position is a rare opportunity to contribute to a groundbreaking CAR T cell program, including launching additional indications; a field-based role that will blend strategic leadership with hands-on field execution, offering a unique chance to shape the trajectory of cellular therapy. As a pivotal team member, you'll navigate the complexities of this field, driving innovation and real-world impact. This field-based role promises an immersive experience at the forefront of medical advancement. If you're prepared to drive transformative change, add value, make an impact and play a pivotal role in advancing cell therapy then this would be an ideal role for you!
**Key Responsibilities include:**
+ Ensure the safe and appropriate use of Gilead therapies and lead scientific exchanges with the medical and scientific communities
+ Facilitate the validation and setup of cell therapy sites and improve the standard of clinical care for patients living with cancer
Scientific Exchange
+ Serve as external scientific expert in the therapy area, healthcare landscape, and data on Gilead and competitor therapies
+ Partner with colleagues and serve as the external medical affairs representative in the cross-functional therapeutic team
+ Identify and establish strategic relationships with key external stakeholders at a national level
+ Collaborate with the cross-functional team to develop and manage national thought leader engagement plans
+ Serve as company ambassador to professional societies, academic & research centres, patient & advocacy groups, and at national & international scientific meetings
+ Develop and present complex scientific and clinical data on Gilead/Kite medicines and related therapy areas
+ Coordinate and answer complex responses to clinical inquiries from healthcare professionals
+ Obtain external insights and support the development and execution of advisory programsServe as liaison for early access programs and compassionate use requests for registered Gilead/Kite therapies
+ Appropriately discuss concepts and coordinate the submission of investigator-sponsored research proposals
Site Validation & Setup
+ Work closely with other field-based employees and head-office staff to proactively support cell therapy sites nationally
+ Partner with Clinical Operations and provides insights into investigator and site selection for Gilead/Kite trials
+ Provide clinical trial recruitment enhancement activities at clinical trial sites and referral centres
+ Implement defined goals and objectives aligned with indication strategic plans
+ Support the training of affiliate staff on therapy area and data relating to Gilead/Kite therapies
+ Ensure all behaviors and activities are in accordance with Medicines Australia Code of Conduct Edition 20
**Knowledge and Experience required:**
+ Advanced scientific or clinical degree preferred
+ Therapeutic experience in haematology &/or cell therapy preferred
+ Functional experience in field medical affairs required
+ Minimum 5 years' experience in the biotechnology or pharmaceutical industry required
+ Excellent written, verbal, relationship-building, influencing, and negotiation skills required
+ Aptitude to understand complex issues, identify key findings, and communicate salient points to varying audiences required
+ Capacity to manage multiple projects simultaneously and effectively prioritize workload required
+ Ability to work with a high level of autonomy and independence required
+ Adherence to all regulatory, legal, and business conduct requirements required
+ Capacity to travel locally, nationally, and internationally when required
**Gilead Core Values**
+ Integrity (always doing the right thing)
+ Teamwork (collaborating in good faith)
+ Excellence (working at a high level of commitment and capability)
+ Accountability (taking personal responsibility)
+ Inclusion (encouraging diversity)
**For Current Gilead Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
**Job Description**
**Gilead Sciences** is a research-based biopharmaceutical company that discovers, develops, and commercialises innovative medicines in areas of unmet medical need. With each new drug discovery and investigational candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include liver viral illnesses, inflammatory diseases, and cancer.
Kite, a Gilead Company, is an organisation engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognise and kill tumours.
Gilead Sciences / Kite, Australia is seeking a knowledgeable and motivated professional capable of working effectively in a cross-functional team environment. The successful candidate will assume a full-time employment as a hybrid head office and field-based Medical Scientist, Kite in the Medical Affairs department and report to the Country Medical Lead, Kite Medical Affairs. This role is based in Queensland and will cover North of Newcastle through to Queensland. Be part of a growing team that values collaboration and fosters an inclusive working environment.
This position is a rare opportunity to contribute to a groundbreaking CAR T cell program, including launching additional indications; a field-based role that will blend strategic leadership with hands-on field execution, offering a unique chance to shape the trajectory of cellular therapy. As a pivotal team member, you'll navigate the complexities of this field, driving innovation and real-world impact. This field-based role promises an immersive experience at the forefront of medical advancement. If you're prepared to drive transformative change, add value, make an impact and play a pivotal role in advancing cell therapy then this would be an ideal role for you!
**Key Responsibilities include:**
+ Ensure the safe and appropriate use of Gilead therapies and lead scientific exchanges with the medical and scientific communities
+ Facilitate the validation and setup of cell therapy sites and improve the standard of clinical care for patients living with cancer
Scientific Exchange
+ Serve as external scientific expert in the therapy area, healthcare landscape, and data on Gilead and competitor therapies
+ Partner with colleagues and serve as the external medical affairs representative in the cross-functional therapeutic team
+ Identify and establish strategic relationships with key external stakeholders at a national level
+ Collaborate with the cross-functional team to develop and manage national thought leader engagement plans
+ Serve as company ambassador to professional societies, academic & research centres, patient & advocacy groups, and at national & international scientific meetings
+ Develop and present complex scientific and clinical data on Gilead/Kite medicines and related therapy areas
+ Coordinate and answer complex responses to clinical inquiries from healthcare professionals
+ Obtain external insights and support the development and execution of advisory programsServe as liaison for early access programs and compassionate use requests for registered Gilead/Kite therapies
+ Appropriately discuss concepts and coordinate the submission of investigator-sponsored research proposals
Site Validation & Setup
+ Work closely with other field-based employees and head-office staff to proactively support cell therapy sites nationally
+ Partner with Clinical Operations and provides insights into investigator and site selection for Gilead/Kite trials
+ Provide clinical trial recruitment enhancement activities at clinical trial sites and referral centres
+ Implement defined goals and objectives aligned with indication strategic plans
+ Support the training of affiliate staff on therapy area and data relating to Gilead/Kite therapies
+ Ensure all behaviors and activities are in accordance with Medicines Australia Code of Conduct Edition 20
**Knowledge and Experience required:**
+ Advanced scientific or clinical degree preferred
+ Therapeutic experience in haematology &/or cell therapy preferred
+ Functional experience in field medical affairs required
+ Minimum 5 years' experience in the biotechnology or pharmaceutical industry required
+ Excellent written, verbal, relationship-building, influencing, and negotiation skills required
+ Aptitude to understand complex issues, identify key findings, and communicate salient points to varying audiences required
+ Capacity to manage multiple projects simultaneously and effectively prioritize workload required
+ Ability to work with a high level of autonomy and independence required
+ Adherence to all regulatory, legal, and business conduct requirements required
+ Capacity to travel locally, nationally, and internationally when required
**Gilead Core Values**
+ Integrity (always doing the right thing)
+ Teamwork (collaborating in good faith)
+ Excellence (working at a high level of commitment and capability)
+ Accountability (taking personal responsibility)
+ Inclusion (encouraging diversity)
**For Current Gilead Employees and Contractors:**
Please apply via the Internal Career Opportunities portal in Workday.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
This advertiser has chosen not to accept applicants from your region.
0
Graduate - Clinical Research Specialist
Perth, Western Australia
Medtronic
Posted 5 days ago
Job Viewed
Job Description
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
**A Day in the Life**
Applications are now open for recent graduates with a degree in Nursing Biomedical or Health Science to join the Clinical Research Team based in Perth, Western Australia. As part of this 12 months contract program, you will develop a breadth of experience across the healthcare continuum, working alongside a group of professionals where you will gain best in class training and mentorship at an individual and team level.
At Medtronic, no two days will be the same! As Graduate - Clinical Research Specialist, you will be able to work with many different teams, learn about breakthrough therapies, gain insight into various parts of the product life cycle and see the impact they have on patients. You will be involved in supporting the administrative and clinical trial execution needs of the studies that you work on and make an impact on the future medical needs of our patients.
This role will enable you to navigate through challenging scenarios, develop your leadership and resilience skills, as well as develop an eye for detail that will allow you to excel in this and future roles.
**Responsibilities may include the following and other duties may be assigned:**
+ Provide support for the execution of Medtronic clinical trials program
+ Responsible for performing and supporting research for teams operating within the clinical research team
+ Assists with the development, monitoring, coordination, and implementation of non-technical projects as assigned.
+ Provides analysis, reporting and internal communication services with team members.
+ Develops knowledge of industry and organizational processes.
+ Exposure to clinical trials processes and execution
**Required Knowledge and Experience:**
+ Bachelor's degree in Nursing, Biomedical or Health Sciences graduate with a thirst for knowledge and a keen interest in medical device
+ Being a proactive thinker and problem solver
+ Having a strong collaborative approach and an ability to work across different teams
+ Excellent communication skills
+ A willingness and enthusiasm to learn new concepts with a growth mindset
**Physical Job Requirements**
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
**Benefits & Compensation**
**Medtronic offers a competitive Salary and flexible Benefits Package**
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
**About Medtronic**
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here ( lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
**We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
**We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
**This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will.
+ **Build** a better future, amplifying your impact on the causes that matter to you and the world
+ **Grow** a career reflective of your passion and abilities
+ **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
**Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
**Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
**Better outcomes for our world** . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
**Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here ( .
For updates on job applications, please go to the candidate login page and sign in to check your application status.
If you need assistance completing your application please email
To request removal of your personal information from our systems please email
**A Day in the Life**
Applications are now open for recent graduates with a degree in Nursing Biomedical or Health Science to join the Clinical Research Team based in Perth, Western Australia. As part of this 12 months contract program, you will develop a breadth of experience across the healthcare continuum, working alongside a group of professionals where you will gain best in class training and mentorship at an individual and team level.
At Medtronic, no two days will be the same! As Graduate - Clinical Research Specialist, you will be able to work with many different teams, learn about breakthrough therapies, gain insight into various parts of the product life cycle and see the impact they have on patients. You will be involved in supporting the administrative and clinical trial execution needs of the studies that you work on and make an impact on the future medical needs of our patients.
This role will enable you to navigate through challenging scenarios, develop your leadership and resilience skills, as well as develop an eye for detail that will allow you to excel in this and future roles.
**Responsibilities may include the following and other duties may be assigned:**
+ Provide support for the execution of Medtronic clinical trials program
+ Responsible for performing and supporting research for teams operating within the clinical research team
+ Assists with the development, monitoring, coordination, and implementation of non-technical projects as assigned.
+ Provides analysis, reporting and internal communication services with team members.
+ Develops knowledge of industry and organizational processes.
+ Exposure to clinical trials processes and execution
**Required Knowledge and Experience:**
+ Bachelor's degree in Nursing, Biomedical or Health Sciences graduate with a thirst for knowledge and a keen interest in medical device
+ Being a proactive thinker and problem solver
+ Having a strong collaborative approach and an ability to work across different teams
+ Excellent communication skills
+ A willingness and enthusiasm to learn new concepts with a growth mindset
**Physical Job Requirements**
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
**Benefits & Compensation**
**Medtronic offers a competitive Salary and flexible Benefits Package**
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
**About Medtronic**
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here ( lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
**We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
**We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
**This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will.
+ **Build** a better future, amplifying your impact on the causes that matter to you and the world
+ **Grow** a career reflective of your passion and abilities
+ **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
**Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
**Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
**Better outcomes for our world** . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
**Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here ( .
For updates on job applications, please go to the candidate login page and sign in to check your application status.
If you need assistance completing your application please email
To request removal of your personal information from our systems please email
This advertiser has chosen not to accept applicants from your region.
1
Clinical Research Associate 2
North Sydney, New South Wales
IQVIA
Posted 6 days ago
Job Viewed
Job Description
Are you passionate about science, driven by purpose, and ready to make a real impact in the world of clinical research? We're looking for a Clinical Research Associate 2 who's ready to take their career to the next level-working on cutting-edge studies that shape the future of medicine. Ideally Sydney or Melbourne. Positions available in our Core and Single sponsor team.
Please note as part of the assessment you will be asked to complete a short video screening interview.
**Essential Functions:**
+ Engage in Site Visits: From selection to close-out, your visits will be pivotal in ensuring the success of our studies.
+ Recruitment Strategies: Develop and implement innovative plans to recruit study subjects, making a tangible impact on project outcomes
+ Empower Sites with Knowledge: Provide essential training and maintain robust communication channels to keep sites aligned and motivated.
+ Champion Quality and Integrity: Evaluate and enhance site practices, ensuring adherence to protocols and regulations.
+ Drive Study Progress: Monitor every aspect of the study, from regulatory submissions to data query resolutions, ensuring seamless execution.
+ Master Documentation: Keep meticulous records and ensure all site documents are perfectly maintained.
+ Collaborate and Innovate: Work closely with a passionate team to support project execution and drive success.
+ Manage Finances with Precision: Oversee site financials and ensure timely invoice retrieval.
**What You Bring**
+ A degree in life sciences or healthcare (or equivalent experience).
+ 18 months minimum on-site Independant monitoring experience to be considered, ideally oncology
+ Deep knowledge of GCP, ICH, and clinical trial operations.
+ Tech-savvy with Microsoft Office and mobile tools (iPhone/iPad).
+ A proactive mindset, strong communication skills, and a passion for excellence.
**Why Join Us?**
+ Work ondiverse, global studiesacross multiple therapeutic areas.
+ Be part of asupportive, innovative teamthat values your growth.
+ Enjoyflexible work arrangements, travel opportunities, and career develop
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
Please note as part of the assessment you will be asked to complete a short video screening interview.
**Essential Functions:**
+ Engage in Site Visits: From selection to close-out, your visits will be pivotal in ensuring the success of our studies.
+ Recruitment Strategies: Develop and implement innovative plans to recruit study subjects, making a tangible impact on project outcomes
+ Empower Sites with Knowledge: Provide essential training and maintain robust communication channels to keep sites aligned and motivated.
+ Champion Quality and Integrity: Evaluate and enhance site practices, ensuring adherence to protocols and regulations.
+ Drive Study Progress: Monitor every aspect of the study, from regulatory submissions to data query resolutions, ensuring seamless execution.
+ Master Documentation: Keep meticulous records and ensure all site documents are perfectly maintained.
+ Collaborate and Innovate: Work closely with a passionate team to support project execution and drive success.
+ Manage Finances with Precision: Oversee site financials and ensure timely invoice retrieval.
**What You Bring**
+ A degree in life sciences or healthcare (or equivalent experience).
+ 18 months minimum on-site Independant monitoring experience to be considered, ideally oncology
+ Deep knowledge of GCP, ICH, and clinical trial operations.
+ Tech-savvy with Microsoft Office and mobile tools (iPhone/iPad).
+ A proactive mindset, strong communication skills, and a passion for excellence.
**Why Join Us?**
+ Work ondiverse, global studiesacross multiple therapeutic areas.
+ Be part of asupportive, innovative teamthat values your growth.
+ Enjoyflexible work arrangements, travel opportunities, and career develop
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
This advertiser has chosen not to accept applicants from your region.
2
Clinical Research Associate 2
Melbourne, Victoria
IQVIA
Posted 6 days ago
Job Viewed
Job Description
Are you passionate about science, driven by purpose, and ready to make a real impact in the world of clinical research? We're looking for a Clinical Research Associate 2 who's ready to take their career to the next level-working on cutting-edge studies that shape the future of medicine. Ideally Sydney or Melbourne. Positions available in our Core and Single sponsor team.
Please note as part of the assessment you will be asked to complete a short video screening interview.
**Essential Functions:**
+ Engage in Site Visits: From selection to close-out, your visits will be pivotal in ensuring the success of our studies.
+ Recruitment Strategies: Develop and implement innovative plans to recruit study subjects, making a tangible impact on project outcomes
+ Empower Sites with Knowledge: Provide essential training and maintain robust communication channels to keep sites aligned and motivated.
+ Champion Quality and Integrity: Evaluate and enhance site practices, ensuring adherence to protocols and regulations.
+ Drive Study Progress: Monitor every aspect of the study, from regulatory submissions to data query resolutions, ensuring seamless execution.
+ Master Documentation: Keep meticulous records and ensure all site documents are perfectly maintained.
+ Collaborate and Innovate: Work closely with a passionate team to support project execution and drive success.
+ Manage Finances with Precision: Oversee site financials and ensure timely invoice retrieval.
**What You Bring**
+ A degree in life sciences or healthcare (or equivalent experience).
+ 18 months minimum on-site Independant monitoring experience to be considered, ideally oncology
+ Deep knowledge of GCP, ICH, and clinical trial operations.
+ Tech-savvy with Microsoft Office and mobile tools (iPhone/iPad).
+ A proactive mindset, strong communication skills, and a passion for excellence.
**Why Join Us?**
+ Work ondiverse, global studiesacross multiple therapeutic areas.
+ Be part of asupportive, innovative teamthat values your growth.
+ Enjoyflexible work arrangements, travel opportunities, and career develop
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
Please note as part of the assessment you will be asked to complete a short video screening interview.
**Essential Functions:**
+ Engage in Site Visits: From selection to close-out, your visits will be pivotal in ensuring the success of our studies.
+ Recruitment Strategies: Develop and implement innovative plans to recruit study subjects, making a tangible impact on project outcomes
+ Empower Sites with Knowledge: Provide essential training and maintain robust communication channels to keep sites aligned and motivated.
+ Champion Quality and Integrity: Evaluate and enhance site practices, ensuring adherence to protocols and regulations.
+ Drive Study Progress: Monitor every aspect of the study, from regulatory submissions to data query resolutions, ensuring seamless execution.
+ Master Documentation: Keep meticulous records and ensure all site documents are perfectly maintained.
+ Collaborate and Innovate: Work closely with a passionate team to support project execution and drive success.
+ Manage Finances with Precision: Oversee site financials and ensure timely invoice retrieval.
**What You Bring**
+ A degree in life sciences or healthcare (or equivalent experience).
+ 18 months minimum on-site Independant monitoring experience to be considered, ideally oncology
+ Deep knowledge of GCP, ICH, and clinical trial operations.
+ Tech-savvy with Microsoft Office and mobile tools (iPhone/iPad).
+ A proactive mindset, strong communication skills, and a passion for excellence.
**Why Join Us?**
+ Work ondiverse, global studiesacross multiple therapeutic areas.
+ Be part of asupportive, innovative teamthat values your growth.
+ Enjoyflexible work arrangements, travel opportunities, and career develop
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
This advertiser has chosen not to accept applicants from your region.
3
Graduate Clinical Research Associate -Victoria
Richmond, New South Wales
Medtronic
Posted 5 days ago
Job Viewed
Job Description
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
**A Day in the Life**
As we enter a new year, applications are now open for recent graduates with a degree in Nursing Biomedical or Health Science to join the Clinical Research Team. As part of this program, you will develop a breadth of experience across the healthcare continuum, working alongside a group of professionals where you will gain best in class training and mentorship at an individual and team level.
At Medtronic, no two days will be the same, in the role you will be able to work with many different teams, learn about breakthrough therapies and see the impact they have on patients. You will be involved in supporting the administrative and clinical trial execution needs of the studies that you work on and make an impact on the future medical needs of our patients. This is the team that works with the frontline technologies. This role will enable you to navigate through challenging scenarios, develop your leadership and resilience skills, as well as develop an eye for detail that will allow you to excel in this and future roles. You will gain insight in to various parts of the product life cycle and you will see first hand the impact you can make using advanced technologies.
**Responsibilities may include the following and other duties may be assigned:**
+ Provide support for the execution of Medtronic clinical trials program
+ Responsible for performing and supporting research for teams operating within the clinical research team
+ Assists with the development, monitoring, coordination, and implementation of non-technical projects as assigned.
+ Provides analysis, reporting and internal communication services with team members.
+ Develops knowledge of industry and organizational processes.
+ Exposure to clinical trials processes and execution
**Required Knowledge and Experience:**
+ Bachelor's Degree in Nursing, Biomedical or Health Sciences graduate with a thirst for knowledge and a keen interest in medical device
+ Being a proactive thinker and problem solver
+ Having a strong collaborative approach and an ability to work across different teams
+ Excellent communication skills
+ A willingness and enthusiasm to learn new concepts with a growth mindset
**Physical Job Requirements**
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
**Benefits & Compensation**
**Medtronic offers a competitive Salary and flexible Benefits Package**
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
**About Medtronic**
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here ( lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
**We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
**We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
**This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will.
+ **Build** a better future, amplifying your impact on the causes that matter to you and the world
+ **Grow** a career reflective of your passion and abilities
+ **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
**Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
**Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
**Better outcomes for our world** . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
**Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here ( .
For updates on job applications, please go to the candidate login page and sign in to check your application status.
If you need assistance completing your application please email
To request removal of your personal information from our systems please email
**A Day in the Life**
As we enter a new year, applications are now open for recent graduates with a degree in Nursing Biomedical or Health Science to join the Clinical Research Team. As part of this program, you will develop a breadth of experience across the healthcare continuum, working alongside a group of professionals where you will gain best in class training and mentorship at an individual and team level.
At Medtronic, no two days will be the same, in the role you will be able to work with many different teams, learn about breakthrough therapies and see the impact they have on patients. You will be involved in supporting the administrative and clinical trial execution needs of the studies that you work on and make an impact on the future medical needs of our patients. This is the team that works with the frontline technologies. This role will enable you to navigate through challenging scenarios, develop your leadership and resilience skills, as well as develop an eye for detail that will allow you to excel in this and future roles. You will gain insight in to various parts of the product life cycle and you will see first hand the impact you can make using advanced technologies.
**Responsibilities may include the following and other duties may be assigned:**
+ Provide support for the execution of Medtronic clinical trials program
+ Responsible for performing and supporting research for teams operating within the clinical research team
+ Assists with the development, monitoring, coordination, and implementation of non-technical projects as assigned.
+ Provides analysis, reporting and internal communication services with team members.
+ Develops knowledge of industry and organizational processes.
+ Exposure to clinical trials processes and execution
**Required Knowledge and Experience:**
+ Bachelor's Degree in Nursing, Biomedical or Health Sciences graduate with a thirst for knowledge and a keen interest in medical device
+ Being a proactive thinker and problem solver
+ Having a strong collaborative approach and an ability to work across different teams
+ Excellent communication skills
+ A willingness and enthusiasm to learn new concepts with a growth mindset
**Physical Job Requirements**
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
**Benefits & Compensation**
**Medtronic offers a competitive Salary and flexible Benefits Package**
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
**About Medtronic**
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Learn more about our business, mission, and our commitment to diversity here ( lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people.
We are engineers at heart- putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
**We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That's who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
**We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
**This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will.
+ **Build** a better future, amplifying your impact on the causes that matter to you and the world
+ **Grow** a career reflective of your passion and abilities
+ **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
**Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
**Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
**Better outcomes for our world** . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
**Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here ( .
For updates on job applications, please go to the candidate login page and sign in to check your application status.
If you need assistance completing your application please email
To request removal of your personal information from our systems please email
This advertiser has chosen not to accept applicants from your region.
4
Senior Clinical Research Associate-FSP
Parexel
Posted 24 days ago
Job Viewed
Job Description
**Key Accountabilities:**
**Maintenance (from initiation through close out):**
Act as PAREXEL's direct contact with assigned sites, assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites, and perform problem-solving to address and resolve site issues.
+ Build relationships with investigators and site staff.
+ Facilitate and support site with access to relevant study systems and ensure sites are compliant with project specific training requirements.
+ Evaluate if on-site staff assignment is still accurate and determine and implement corrective actions & follow-up, if necessary / relevant.
+ Address and resolve issues at sites, including the need for additional training, potential deficiencies in documentation, and communication.
+ Address/evaluate/resolve issues pending from the previous visit, if any.
+ Follow-up on and respond to appropriate site related questions.
+ Apply working knowledge and judgment to identify and evaluate potential data quality and data integrity issues. Determine and implement appropriate follow-up action.
+ Actively participate in Investigator and other external or internal meetings and audits & regulatory inspections as required.
+ Collect, review, and approve (if applicable) updated/amended site documentation, including regulatory documents as applicable.
+ Evaluate site recruitment plan in collaboration with the site staff on an ongoing basis and provide strategy for improvements.
+ Perform on-site visits; this includes Qualification and Initiation visits; apply judgment and knowledge to independently resolve site issues, questions and concerns.
+ Conduct remote visits/contacts as requested/needed.
+ Generate visit/contact report.
+ Evaluate overall compliance and performance of sites and site staff: provide recommendations regarding site-specific actions and use judgment and experience to assess the ability and motivation of site staff.
+ Assess & manage test article/study supply including supply, accountability and destruction/return status.
+ Review & follow-up site payment status.
+ Follow-up on CRF data entry, query status, and SAEs.
+ Conduct on-site study-specific training (if applicable).
+ Perform site facilities assessments
+ Recognize impact of study non-compliance/issues/delays/changes on study timelines and communicate study issues that require immediate action, with proposed strategy for resolution
**Overall Accountabilities from Site Identification to Close out:**
Ensure timely and accurate completion of project goals and update of applicable trial management systems.
+ Work with team members to meet project goals, provide strategy for efficient project planning and goal completion, and encourage the support of team members where required.
+ Update all appropriate Clinical Trial Management Systems (CTMS) on an ongoing basis, including performing regular reviews of site level data in clinical systems (e.g. CTMS, EDC, IVRS, and SIS) and ensure timely and high quality data entry compliance from sites, manage and submit all relevant documents to the Trial Master File (TMF), ensuring first time quality, and distribute study documents to site including configuration of Investigator Site Files if applicable and on-going maintenance for completeness and quality.
+ Ensure that assigned sites are audit and inspection ready
+ Monitor and maintain compliance with ICH-GCP and applicable international and local regulations.
+ Delegate administrative and other tasks to Administrative Support Team as needed and where appropriate. Guide Administrative Support Team members, review work, and provide feedback to manager regarding performance.
+ Show commitment and perform consistent high-quality work.
+ Maintain a positive, results-orientated work environment, building partnerships and collaborative relationships, communicating with team(s) in an open, balanced, objective manner, modeling the high performance culture values.
+ Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, Parexel SOPs, other Parexel / Sponsor training requirements and study specific procedures, plans and training.
+ Ensure basic understanding of project scope, milestones, budgets, and strive for high quality, timely, and efficient delivery.
+ Provide input and feedback for Performance Development Conversation(s).
+ Proactively keep manager informed about work progress and any issues.
+ Develop expertise to become a subject matter expert.
+ Work in a self-driven capacity, with limited need for oversight.
+ Complete additional tasks in a timely manner (e.g. timesheets, expenses, metrics, etc.)
**Skills:**
+ Sound problem solving skills.
+ Able to take initiative and work independently, and to proactively seek guidance when necessary.
+ Advance presentation skills.
+ Client focused approach to work.
+ Ability to interact professionally within a client organization.
+ Flexible attitude with respect to work assignments and new learning.
+ Ability to prioritize multiple tasks and achieve project timelines; utilizing strong analytical skills to make decision autonomously due to the unpredictable nature of the issues that arise.
+ Willingness to work in a matrix environment and to value the importance of teamwork.
+ Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word.
+ Strong interpersonal, verbal, and written communication skills.
+ Sense of urgency in completing assigned tasks and ability to assist others to meet study/country deliverables and preserving patient safety.
+ Effective time management in order to meet study needs, team objectives, and department goals.
+ Developing ability to work across cultures.
+ Shows commitment to and performs consistently high-quality work.
+ Ability to successfully work in a ('virtual') team environment.
+ Consulting Skills
+ Great attention to detail.
+ Able to accommodate extensive travel time requirements, according to tasks allocation/phase of the study assigned.
+ Holds a driver's license where required.
**Knowledge and Experience:**
+ Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology
**Education:**
+ Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience
#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
**Maintenance (from initiation through close out):**
Act as PAREXEL's direct contact with assigned sites, assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites, and perform problem-solving to address and resolve site issues.
+ Build relationships with investigators and site staff.
+ Facilitate and support site with access to relevant study systems and ensure sites are compliant with project specific training requirements.
+ Evaluate if on-site staff assignment is still accurate and determine and implement corrective actions & follow-up, if necessary / relevant.
+ Address and resolve issues at sites, including the need for additional training, potential deficiencies in documentation, and communication.
+ Address/evaluate/resolve issues pending from the previous visit, if any.
+ Follow-up on and respond to appropriate site related questions.
+ Apply working knowledge and judgment to identify and evaluate potential data quality and data integrity issues. Determine and implement appropriate follow-up action.
+ Actively participate in Investigator and other external or internal meetings and audits & regulatory inspections as required.
+ Collect, review, and approve (if applicable) updated/amended site documentation, including regulatory documents as applicable.
+ Evaluate site recruitment plan in collaboration with the site staff on an ongoing basis and provide strategy for improvements.
+ Perform on-site visits; this includes Qualification and Initiation visits; apply judgment and knowledge to independently resolve site issues, questions and concerns.
+ Conduct remote visits/contacts as requested/needed.
+ Generate visit/contact report.
+ Evaluate overall compliance and performance of sites and site staff: provide recommendations regarding site-specific actions and use judgment and experience to assess the ability and motivation of site staff.
+ Assess & manage test article/study supply including supply, accountability and destruction/return status.
+ Review & follow-up site payment status.
+ Follow-up on CRF data entry, query status, and SAEs.
+ Conduct on-site study-specific training (if applicable).
+ Perform site facilities assessments
+ Recognize impact of study non-compliance/issues/delays/changes on study timelines and communicate study issues that require immediate action, with proposed strategy for resolution
**Overall Accountabilities from Site Identification to Close out:**
Ensure timely and accurate completion of project goals and update of applicable trial management systems.
+ Work with team members to meet project goals, provide strategy for efficient project planning and goal completion, and encourage the support of team members where required.
+ Update all appropriate Clinical Trial Management Systems (CTMS) on an ongoing basis, including performing regular reviews of site level data in clinical systems (e.g. CTMS, EDC, IVRS, and SIS) and ensure timely and high quality data entry compliance from sites, manage and submit all relevant documents to the Trial Master File (TMF), ensuring first time quality, and distribute study documents to site including configuration of Investigator Site Files if applicable and on-going maintenance for completeness and quality.
+ Ensure that assigned sites are audit and inspection ready
+ Monitor and maintain compliance with ICH-GCP and applicable international and local regulations.
+ Delegate administrative and other tasks to Administrative Support Team as needed and where appropriate. Guide Administrative Support Team members, review work, and provide feedback to manager regarding performance.
+ Show commitment and perform consistent high-quality work.
+ Maintain a positive, results-orientated work environment, building partnerships and collaborative relationships, communicating with team(s) in an open, balanced, objective manner, modeling the high performance culture values.
+ Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, Parexel SOPs, other Parexel / Sponsor training requirements and study specific procedures, plans and training.
+ Ensure basic understanding of project scope, milestones, budgets, and strive for high quality, timely, and efficient delivery.
+ Provide input and feedback for Performance Development Conversation(s).
+ Proactively keep manager informed about work progress and any issues.
+ Develop expertise to become a subject matter expert.
+ Work in a self-driven capacity, with limited need for oversight.
+ Complete additional tasks in a timely manner (e.g. timesheets, expenses, metrics, etc.)
**Skills:**
+ Sound problem solving skills.
+ Able to take initiative and work independently, and to proactively seek guidance when necessary.
+ Advance presentation skills.
+ Client focused approach to work.
+ Ability to interact professionally within a client organization.
+ Flexible attitude with respect to work assignments and new learning.
+ Ability to prioritize multiple tasks and achieve project timelines; utilizing strong analytical skills to make decision autonomously due to the unpredictable nature of the issues that arise.
+ Willingness to work in a matrix environment and to value the importance of teamwork.
+ Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word.
+ Strong interpersonal, verbal, and written communication skills.
+ Sense of urgency in completing assigned tasks and ability to assist others to meet study/country deliverables and preserving patient safety.
+ Effective time management in order to meet study needs, team objectives, and department goals.
+ Developing ability to work across cultures.
+ Shows commitment to and performs consistently high-quality work.
+ Ability to successfully work in a ('virtual') team environment.
+ Consulting Skills
+ Great attention to detail.
+ Able to accommodate extensive travel time requirements, according to tasks allocation/phase of the study assigned.
+ Holds a driver's license where required.
**Knowledge and Experience:**
+ Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology
**Education:**
+ Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience
#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
This advertiser has chosen not to accept applicants from your region.
5
Senior Clinical Research Associate-FSP
Parexel
Posted 24 days ago
Job Viewed
Job Description
**Key Accountabilities:**
**Maintenance (from initiation through close out):**
Act as PAREXEL's direct contact with assigned sites, assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites, and perform problem-solving to address and resolve site issues.
+ Build relationships with investigators and site staff.
+ Facilitate and support site with access to relevant study systems and ensure sites are compliant with project specific training requirements.
+ Evaluate if on-site staff assignment is still accurate and determine and implement corrective actions & follow-up, if necessary / relevant.
+ Address and resolve issues at sites, including the need for additional training, potential deficiencies in documentation, and communication.
+ Address/evaluate/resolve issues pending from the previous visit, if any.
+ Follow-up on and respond to appropriate site related questions.
+ Apply working knowledge and judgment to identify and evaluate potential data quality and data integrity issues. Determine and implement appropriate follow-up action.
+ Actively participate in Investigator and other external or internal meetings and audits & regulatory inspections as required.
+ Collect, review, and approve (if applicable) updated/amended site documentation, including regulatory documents as applicable.
+ Evaluate site recruitment plan in collaboration with the site staff on an ongoing basis and provide strategy for improvements.
+ Perform on-site visits; this includes Qualification and Initiation visits; apply judgment and knowledge to independently resolve site issues, questions and concerns.
+ Conduct remote visits/contacts as requested/needed.
+ Generate visit/contact report.
+ Evaluate overall compliance and performance of sites and site staff: provide recommendations regarding site-specific actions and use judgment and experience to assess the ability and motivation of site staff.
+ Assess & manage test article/study supply including supply, accountability and destruction/return status.
+ Review & follow-up site payment status.
+ Follow-up on CRF data entry, query status, and SAEs.
+ Conduct on-site study-specific training (if applicable).
+ Perform site facilities assessments
+ Recognize impact of study non-compliance/issues/delays/changes on study timelines and communicate study issues that require immediate action, with proposed strategy for resolution
**Overall Accountabilities from Site Identification to Close out:**
Ensure timely and accurate completion of project goals and update of applicable trial management systems.
+ Work with team members to meet project goals, provide strategy for efficient project planning and goal completion, and encourage the support of team members where required.
+ Update all appropriate Clinical Trial Management Systems (CTMS) on an ongoing basis, including performing regular reviews of site level data in clinical systems (e.g. CTMS, EDC, IVRS, and SIS) and ensure timely and high quality data entry compliance from sites, manage and submit all relevant documents to the Trial Master File (TMF), ensuring first time quality, and distribute study documents to site including configuration of Investigator Site Files if applicable and on-going maintenance for completeness and quality.
+ Ensure that assigned sites are audit and inspection ready
+ Monitor and maintain compliance with ICH-GCP and applicable international and local regulations.
+ Delegate administrative and other tasks to Administrative Support Team as needed and where appropriate. Guide Administrative Support Team members, review work, and provide feedback to manager regarding performance.
+ Show commitment and perform consistent high-quality work.
+ Maintain a positive, results-orientated work environment, building partnerships and collaborative relationships, communicating with team(s) in an open, balanced, objective manner, modeling the high performance culture values.
+ Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, Parexel SOPs, other Parexel / Sponsor training requirements and study specific procedures, plans and training.
+ Ensure basic understanding of project scope, milestones, budgets, and strive for high quality, timely, and efficient delivery.
+ Provide input and feedback for Performance Development Conversation(s).
+ Proactively keep manager informed about work progress and any issues.
+ Develop expertise to become a subject matter expert.
+ Work in a self-driven capacity, with limited need for oversight.
+ Complete additional tasks in a timely manner (e.g. timesheets, expenses, metrics, etc.)
**Skills:**
+ Sound problem solving skills.
+ Able to take initiative and work independently, and to proactively seek guidance when necessary.
+ Advance presentation skills.
+ Client focused approach to work.
+ Ability to interact professionally within a client organization.
+ Flexible attitude with respect to work assignments and new learning.
+ Ability to prioritize multiple tasks and achieve project timelines; utilizing strong analytical skills to make decision autonomously due to the unpredictable nature of the issues that arise.
+ Willingness to work in a matrix environment and to value the importance of teamwork.
+ Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word.
+ Strong interpersonal, verbal, and written communication skills.
+ Sense of urgency in completing assigned tasks and ability to assist others to meet study/country deliverables and preserving patient safety.
+ Effective time management in order to meet study needs, team objectives, and department goals.
+ Developing ability to work across cultures.
+ Shows commitment to and performs consistently high-quality work.
+ Ability to successfully work in a ('virtual') team environment.
+ Consulting Skills
+ Great attention to detail.
+ Able to accommodate extensive travel time requirements, according to tasks allocation/phase of the study assigned.
+ Holds a driver's license where required.
**Knowledge and Experience:**
+ Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology
**Education:**
+ Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience
#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
**Maintenance (from initiation through close out):**
Act as PAREXEL's direct contact with assigned sites, assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites, and perform problem-solving to address and resolve site issues.
+ Build relationships with investigators and site staff.
+ Facilitate and support site with access to relevant study systems and ensure sites are compliant with project specific training requirements.
+ Evaluate if on-site staff assignment is still accurate and determine and implement corrective actions & follow-up, if necessary / relevant.
+ Address and resolve issues at sites, including the need for additional training, potential deficiencies in documentation, and communication.
+ Address/evaluate/resolve issues pending from the previous visit, if any.
+ Follow-up on and respond to appropriate site related questions.
+ Apply working knowledge and judgment to identify and evaluate potential data quality and data integrity issues. Determine and implement appropriate follow-up action.
+ Actively participate in Investigator and other external or internal meetings and audits & regulatory inspections as required.
+ Collect, review, and approve (if applicable) updated/amended site documentation, including regulatory documents as applicable.
+ Evaluate site recruitment plan in collaboration with the site staff on an ongoing basis and provide strategy for improvements.
+ Perform on-site visits; this includes Qualification and Initiation visits; apply judgment and knowledge to independently resolve site issues, questions and concerns.
+ Conduct remote visits/contacts as requested/needed.
+ Generate visit/contact report.
+ Evaluate overall compliance and performance of sites and site staff: provide recommendations regarding site-specific actions and use judgment and experience to assess the ability and motivation of site staff.
+ Assess & manage test article/study supply including supply, accountability and destruction/return status.
+ Review & follow-up site payment status.
+ Follow-up on CRF data entry, query status, and SAEs.
+ Conduct on-site study-specific training (if applicable).
+ Perform site facilities assessments
+ Recognize impact of study non-compliance/issues/delays/changes on study timelines and communicate study issues that require immediate action, with proposed strategy for resolution
**Overall Accountabilities from Site Identification to Close out:**
Ensure timely and accurate completion of project goals and update of applicable trial management systems.
+ Work with team members to meet project goals, provide strategy for efficient project planning and goal completion, and encourage the support of team members where required.
+ Update all appropriate Clinical Trial Management Systems (CTMS) on an ongoing basis, including performing regular reviews of site level data in clinical systems (e.g. CTMS, EDC, IVRS, and SIS) and ensure timely and high quality data entry compliance from sites, manage and submit all relevant documents to the Trial Master File (TMF), ensuring first time quality, and distribute study documents to site including configuration of Investigator Site Files if applicable and on-going maintenance for completeness and quality.
+ Ensure that assigned sites are audit and inspection ready
+ Monitor and maintain compliance with ICH-GCP and applicable international and local regulations.
+ Delegate administrative and other tasks to Administrative Support Team as needed and where appropriate. Guide Administrative Support Team members, review work, and provide feedback to manager regarding performance.
+ Show commitment and perform consistent high-quality work.
+ Maintain a positive, results-orientated work environment, building partnerships and collaborative relationships, communicating with team(s) in an open, balanced, objective manner, modeling the high performance culture values.
+ Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, Parexel SOPs, other Parexel / Sponsor training requirements and study specific procedures, plans and training.
+ Ensure basic understanding of project scope, milestones, budgets, and strive for high quality, timely, and efficient delivery.
+ Provide input and feedback for Performance Development Conversation(s).
+ Proactively keep manager informed about work progress and any issues.
+ Develop expertise to become a subject matter expert.
+ Work in a self-driven capacity, with limited need for oversight.
+ Complete additional tasks in a timely manner (e.g. timesheets, expenses, metrics, etc.)
**Skills:**
+ Sound problem solving skills.
+ Able to take initiative and work independently, and to proactively seek guidance when necessary.
+ Advance presentation skills.
+ Client focused approach to work.
+ Ability to interact professionally within a client organization.
+ Flexible attitude with respect to work assignments and new learning.
+ Ability to prioritize multiple tasks and achieve project timelines; utilizing strong analytical skills to make decision autonomously due to the unpredictable nature of the issues that arise.
+ Willingness to work in a matrix environment and to value the importance of teamwork.
+ Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word.
+ Strong interpersonal, verbal, and written communication skills.
+ Sense of urgency in completing assigned tasks and ability to assist others to meet study/country deliverables and preserving patient safety.
+ Effective time management in order to meet study needs, team objectives, and department goals.
+ Developing ability to work across cultures.
+ Shows commitment to and performs consistently high-quality work.
+ Ability to successfully work in a ('virtual') team environment.
+ Consulting Skills
+ Great attention to detail.
+ Able to accommodate extensive travel time requirements, according to tasks allocation/phase of the study assigned.
+ Holds a driver's license where required.
**Knowledge and Experience:**
+ Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology
**Education:**
+ Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience
#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
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