Apply on Employer Site

Planet Pharma · 2 hours ago

Clinical Monitoring Specialist

California, United States

Full-time

Onsite

Senior Level

$50/hr - $60/hr

5+ years exp

Planet Pharma is seeking a Clinical Monitoring Specialist to oversee and monitor clinical trial activities. The role involves ensuring compliance with protocols, validating data integrity, and conducting onsite visits to support trial operations.

BiotechnologyHealth CarePharmaceutical

Responsibilities

Provide oversight of and insights into trial activities (e.g., trends in protocol compliance, enrollment, monitoring deviations, data quality) to principal investigators and support staff, and study sponsor management and leadership staff, including Institutional Review Boards/Ethics Committees/Research Ethics Committees, Clinical Operations (e.g. Contracts), and recommend and develop process improvements

Verify trial/study data, including maintaining appropriate regulatory documents both internal and external, auditing to be sure the site has the appropriate regulatory documentation to conduct the trial/study, and source documentation is properly recorded

Validate investigational device accountability by tracking the history of investigational devices from Edwards to the field sites and through final disposition

Conduct onsite monitor visits