Senior Clinical Research Associate I (SCRA1) - Sydney, Melbourne, Perth, Adelaide or Brisbane
Fortrea
Sydney
6 days ago
Senior Clinical Research Associate I (SCRA1) - Sydney, Melbourne, Perth, Adelaide or Brisbane
Fortrea is seeking a Senior Clinical Research Associate I (SCRA1) to manage and monitor clinical study sites in Australia. The role requires extensive travel (60-80%), a bachelor's degree in life sciences, and a minimum of 3 years of clinical onsite monitoring experience.
On-site
Full-time
Senior
Site Management
Regulatory Requirements
Salary
Not specified
Core Qualifications
Technical (Must-have)
site managementregulatory requirementsdrug development processessource document reviewCase Report Formsmonitoring reportsfeasibility assessmentsbudget negotiationsregulatory submissions
Soft Skills
communicationorganizationalproblem-solvingmentoringteamwork
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.
Senior Clinical Research AssociateClinical TrialsSite MonitoringCROPharmaceuticalLife SciencesOn-siteFull-timeAustraliaBiotechnology