Description
As a Senior Clinical Research Associate I at Fortrea, you will play a pivotal role in ensuring the success of clinical trials by managing and monitoring study sites.
You’ll work 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.
- Strong knowledge of regulatory requirements and drug development processes.
- Advanced site management skills.
- Excellent communication, organisational, 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?
- Contribute to groundbreaking research that improves lives worldwide.
- Access robust training, mentorship, and advancement opportunities.
- Thrive in a collaborative, inclusive environment that values work-life balance.
- Be part of a forward-thinking organisation shaping the future of clinical trials.