Clinical Research Associate

Melbourne, Victoria ICON Clinical Research

Posted 16 days ago

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Clinical Research Associate - Home-based in Australia
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
We are currently seeking a Clinical Research Associate (CRA) to join our diverse and dynamic team. As a CRA at ICON Plc, you will play a critical role in overseeing and managing clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards. You will contribute to the success of clinical trials by ensuring data integrity, participant safety, and compliance throughout the study lifecycle.
**What You Will Be Doing:**
+ Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
+ Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.
+ Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting.
+ Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.
+ Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.
**Your Profile:**
+ Advanced degree in a relevant field such as life sciences, nursing, or medicine.
+ Extensive experience as a Clinical Research Associate, (min. 2 years of independent monitoring experience) with a strong understanding of clinical trial processes and regulatory requirements.
+ Proven ability to manage multiple sites and projects simultaneously, with strong organizational and problem-solving skills.
+ Expertise in monitoring practices, data integrity, and site management, with proficiency in relevant clinical trial software and tools.
+ Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive compliance within a complex environment.
+ Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license
**What ICON can offer you:**
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
+ Various annual leave entitlements
+ A range of health insurance offerings to suit you and your family's needs.
+ Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
+ Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
+ Life assurance
+ Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site ( to read more about the benefits ICON offers.
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here ( in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Are you a current ICON Employee? Please click here ( to apply
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Clinical Research Associate 1

Melbourne, Victoria IQVIA

Posted 3 days ago

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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 1 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. This role is on our 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).
+ 12 months minimum on-site Independant monitoring experience to be considered, ideally haemotology.
+ 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 on diverse, global studies across multiple therapeutic areas.
+ Be part of a supportive, innovative team that values your growth.
+ Enjoy flexible 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.

Clinical Research Associate 1

Melbourne, Victoria IQVIA

Posted 3 days ago

Job Viewed

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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 1 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. This role is on our 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).
+ 12 months minimum on-site Independant monitoring experience to be considered, ideally haemotology.
+ 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.

Clinical Research Associate 2

Melbourne, Victoria IQVIA

Posted 17 days ago

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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. This role is on our 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 haemotology.
+ 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.

Clinical Research Associate (CRA) II/ Senior CRA (FSP) | Melbourne, Sydney, Brisbane

Melbourne, Victoria ThermoFisher Scientific

Posted 14 days ago

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Job Description

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
**Summarized Purpose:**
Performs and coordinates different aspects of the clinical monitoring and site management process. Conducts remote or on-site visits to assess protocol and regulatory compliance and manages required documentation. Manages procedures and guidelines from different sponsors and/or supervising environments (i.e. FSO, FSP, Government, etc.). Acts as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. Ensures audit readiness. Develops collaborative relationships with investigational sites. Detailed tasks and responsibilities assigned to role are outlined in the task matrix.
**Location Information**
This is a home-based position and preferably based in **Melbourne, Sydney or Brisbane.**
**Key responsibilities**
+ Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks. Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities. Assess investigational product through physical inventory and records review. Documents observations in reports and letters in a timely manner using approved business writing standards. Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner. Conducts supervising tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.
+ Participates in investigator meetings as vital. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites. Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.
+ Ensures that required crucial documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
+ Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System).
+ Facilitates effective communication between investigative sites, the client company and the PPD project team through written, oral and/or electronic contacts.
+ Responds to company, client and applicable regulatory requirements/audits/inspections.
+ Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner.
+ Contributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.
+ Contributes to other project work and initiatives for process improvement, as required.
**Keys to Success**
**Education and Experience:**
+ Bachelor's degree in a life sciences related fielder a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.
+ Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1 years as a clinical research monitor) or completion of PPD Drug Development Fellowship. Valid driver's license where applicable.
+ **Therapeutic experience in Oncology essential**
+ **Phase I experience essential**
**Knowledge, Skills and Abilities:**
+ Proven clinical monitoring skills.
+ Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
+ Demonstrated ability to attain and maintain a solid understanding of ICH GCPs, applicable regulations and procedural documents.
+ Well-developed critical thinking skills, including but not limited to: critical mindset, in-depth investigation for appropriate root cause analysis and problem solving
+ Ability to manage Risk Based Monitoring concepts and processes.
+ Good oral and written communication skills, with the ability to communicate effectively with medical personnel.
+ Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers' underlying issues.
+ Good organizational and time management skills
+ Effective interpersonal skills.
+ Attention to detail.
+ Ability to remain flexible and adaptable in a wide range of scenarios.
+ Ability to work in a team or independently as required.
+ Good digital literacy: solid knowledge of Microsoft Office and the ability to learn appropriate software.
+ Good English language and grammar skills.
+ Good presentation skills.
+ Australian citizenship or permanent residency required
**Benefits**
**Join our team and take advantage of these great benefits! Apply now to learn more about the full range of benefits we offer.**
+ **Health & Wellbeing:**  Join a company that prioritizes your health & wellbeing with comprehensive benefits, wellness programs, and an Employee Assistance Program providing confidential support for personal and work-related issues.
+ **Flexibility:**  Balance your work and personal life with flexible arrangements.
+ **Extra Leave:**  Benefit from generous leave policies, including the option to purchaseadditional leave, paid birthday leave, and company paid parental leave.
+ **Charitable Giving & Volunteering:**  Make an impact with paid volunteer time to support non-profit organizations that matter to you.
+ **Learning & Development:**  Advance your career with access to online courses via Thermo Fisher Scientific University Plus and LinkedIn learning, workshops, and mentorship programs for continuous learning and skill development.
**Thermo Fisher Scientific** **Australia** **W** **GEA Employer of Choice for Gender Equality**
We offer competitive remuneration, annual incentive plan bonus, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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