Clinical Study Manager
1 week ago
Treace is a dynamic company dedicated to improving patient outcomes and reducing healthcare costs through innovative solutions. As a Clinical Research Associate, you will play a critical role in achieving our mission by overseeing clinical trial activities at investigational sites, conducting and writing accurate visit reports, and ensuring compliance with Good Clinical Practices (GCP) and monitoring plans.
Key Responsibilities:- Ensure study investigators and coordinators comply with the study protocol, Good Clinical Practices (GCPs), Code of Federal Regulations (CFRs), and Institutional Review Board (IRB)/Ethics Committee (EC) requirements during clinical studies
- Act as primary liaison to clinical sites
- Conduct remote and in-person site qualification visits, study start-up activities, site qualification visits, site initiation visits and training, monitoring visits for source data verification, and site close-out visits
- Generate high-quality site qualification, initiation, monitoring, and close-out visit reports in a timely manner
- Contribute to protocol, informed consent, case report form (CRF) and study plan development as well as annual progress reports (APRs) and the clinical study report (CSR) at study conclusion
- Ensure the rights and well-being of human subjects are protected and confirm data quality/integrity
Estimated Salary: $95,000 - $115,000 per year
This job operates in a professional office environment. The employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms. This position may require prolonged periods of sitting and working on a computer or standing as well as the ability to bend and lift up to 20 lbs.
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