Senior Clinical Research Associate I (SSydney, Melbourne, …
Senior Clinical Research Associate I (SSydney, Melbourne, …
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Melbourne, Australia
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Posted: less than a week ago
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Description
Fortrea is a global team redefining clinical research, inviting professionals to contribute to impactful work. About the Role As a Senior Clinical Research Associate I, you will manage and monitor clinical study sites, working closely with investigators and sponsors to uphold regulatory standards and deliver high‑quality data that advances medical breakthroughs. Key Responsibilities
- Monitor and manage clinical study sites, including initiation, routine visits, and closeout activities.
- Ensure patient safety and compliance with informed consent and protocol requirements.
- Review source documents and verify data integrity on Case Report Forms (CRFs).
- Prepare accurate and timely monitoring reports and maintain study files.
- Serve as lead monitor for assigned protocols and assist in developing monitoring plans.
- Coordinate with vendors and internal teams to meet project timelines and objectives.
- Support feasibility assessments, budget negotiations, and regulatory submissions.
- Mentor and train junior team members through co‑monitoring and guidance.
- Travel extensively (60–80%) to support site activities and maintain audit readiness. Qualifications
- Bachelor’s degree in life sciences or related field, or equivalent clinical research experience.
- Typically a minimum of 3 years clinical onsite monitoring experience in pharmaceutical or CRO settings.
- Solid knowledge of regulatory requirements and drug development processes.
- Advanced site management skills.
- Excellent communication, organizational, and problem‑solving abilities.
- Proficiency in relevant computer applications and systems.
- Valid driver’s license and ability to travel extensively.
- Have the rights to work in Australia. Sorry, no visa sponsorship support offered at this time. Why Join Fortrea?
- Global Impact: Contribute to groundbreaking research that improves lives worldwide.
- Career Development: Access robust training, mentorship, and advancement opportunities.
- Flexibility & Support: Thrive in a collaborative, inclusive environment that values work‑life balance.
- Innovation: Be part of a forward‑thinking organization shaping the future of clinical trials. Fortrea is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Learn more about our EEO & Accommodations request here. #J-18808-Ljbffr Apply on Kit Job: kitjobau.com/job/3rvzvd
- Monitor and manage clinical study sites, including initiation, routine visits, and closeout activities.
- Ensure patient safety and compliance with informed consent and protocol requirements.
- Review source documents and verify data integrity on Case Report Forms (CRFs).
- Prepare accurate and timely monitoring reports and maintain study files.
- Serve as lead monitor for assigned protocols and assist in developing monitoring plans.
- Coordinate with vendors and internal teams to meet project timelines and objectives.
- Support feasibility assessments, budget negotiations, and regulatory submissions.
- Mentor and train junior team members through co‑monitoring and guidance.
- Travel extensively (60–80%) to support site activities and maintain audit readiness. Qualifications
- Bachelor’s degree in life sciences or related field, or equivalent clinical research experience.
- Typically a minimum of 3 years clinical onsite monitoring experience in pharmaceutical or CRO settings.
- Solid knowledge of regulatory requirements and drug development processes.
- Advanced site management skills.
- Excellent communication, organizational, and problem‑solving abilities.
- Proficiency in relevant computer applications and systems.
- Valid driver’s license and ability to travel extensively.
- Have the rights to work in Australia. Sorry, no visa sponsorship support offered at this time. Why Join Fortrea?
- Global Impact: Contribute to groundbreaking research that improves lives worldwide.
- Career Development: Access robust training, mentorship, and advancement opportunities.
- Flexibility & Support: Thrive in a collaborative, inclusive environment that values work‑life balance.
- Innovation: Be part of a forward‑thinking organization shaping the future of clinical trials. Fortrea is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Learn more about our EEO & Accommodations request here. #J-18808-Ljbffr Apply on Kit Job: kitjobau.com/job/3rvzvd
Highlights
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Company nameFortrea
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Job positionSenior Clinical Research Associate I (SSydney, Melbourne, Perth, Adelaide or Brisbane
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