Cynet Systems · 2 months ago
Senior Clinical Research Monitoring Specialist (Field)
Cynet Systems is a confidential company seeking a Senior Clinical Research Monitoring Specialist to oversee trial activities and provide insights to various stakeholders. The role involves verifying trial data, maintaining regulatory documents, and conducting onsite monitor visits.
EmploymentRecruitingStaffing Agency
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 the client to the field sites and through final disposition
Conduct onsite monitor visits
Qualification
Required
Bachelor's Degree or equivalent in a related field
5-7 years of experience required