Human Subject Research Specialist I
Core
Coordinates administrative details and participant adherence for human subject research studies in OBGYN.
Role type
Human Subject Research Specialist (Clinical Research Coordinator)
Builds
Clinical research studies for OBGYN patients
Domain
Healthcare / Clinical Research
Required skills
Protocol adherence monitoring, Patient recruitment and screening, Medical chart review, Adverse event reporting, Regulatory compliance, Data collection and documentation, Staff training on study procedures, Liaison with sponsors
Preferred skills
Phlebotomy experience, Data analysis software, Word processing
Responsibilities
Coordinate administrative details for initiating and conducting human subject research; Assist in human subject recruitment and screening by reviewing patient databases and conducting telephone interviews; Conduct visits to ensure participant adherence with protocol requirements and document adverse events; Train staff on protocol details, informed consent, and case report form completion; Act as liaison with Sponsor's Monitor for data clarifications and monitoring visits; Maintain knowledge of federal, state, and institutional policies and Good Clinical Practice standards.