Clinical Research Coordinator - Epidemiology

Mayo Clinic•Rochester, MN

About The Position

Independently coordinates complex clinical research protocols, including interventional and therapeutic studies greater than minimal risk, with minimal direction from the principal investigator and/or supervisor. Works with the research team to assess protocol feasibility and management, implements protocols after IRB approval, and provides information for progress reports. Screens, enrolls, and recruits research participants; coordinates schedules and monitors research activities and participant involvement. Reviews and reports adverse events, protocol deviations, and other unanticipated problems. Manages, monitors, and reports research data to maintain quality and compliance, provides education and training to others in the department, and performs study-related administrative and regulatory duties. Some travel may be required. Protocol development and maintenance may include managing protocol documents and processes through editing, amendments, and proofing; coordinating study logistics such as blood collection kits, data collection booklets, and use of the CRU; and verifying content against institutional and federal standards. The coordinator may communicate with study sites and federal agencies about study status changes, prepare and submit federal and IRB documents, and provide consultative expertise on regulatory and policy requirements. The role also applies investigators’ scientific data to protocol documents and associated procedures in accordance with internal and external policies and regulatory requirements, participates in other protocol development activities, and completes other assigned work. This position is 0.70 FTE (56 hours per pay period, or every two weeks). Visa sponsorship is unavailable, and the position is not eligible for the F-1 OPT STEM extension.

Requirements

High school diploma and at least 5 years of clinical research coordination or related experience; or an associate degree/college diploma/certificate program and at least 3 years of experience; or an associate degree in Clinical Research from an accredited academic institution without experience; or a bachelor’s degree and at least 1 year of experience, or completion of a Mayo Clinic-sponsored clinical research internship in lieu of 1 year of experience.
Experience should be in a clinical setting or a related area.

Nice To Haves

Graduate or diploma from a study coordinator training program.
One year of clinical research experience.
Medical terminology course.

Responsibilities

Coordinate complex clinical research protocols with minimal direction from the principal investigator and/or supervisor.
Collaborate with the research team to assess protocol feasibility and management.
Implement research protocols after IRB approval and provide information for progress reports.
Screen, enroll, and recruit research participants.
Coordinate schedules and monitor research activities and participant participation.
Identify, review, and report adverse events, protocol deviations, and other unanticipated problems.
Manage, monitor, and report research data to maintain quality and compliance.
Provide education and training to others within the department.
Perform study-related administrative and regulatory duties.
Manage protocol documents and processes, including editing, amendments, and proofing.
Coordinate study logistics, including blood collection kits, data collection booklets, and use of the CRU.
Verify protocol content meets institutional and federal standards.
Communicate with study sites and/or federal agencies regarding study status changes.
Prepare and submit federal and Institutional Review Board documents.
Provide consultative expertise regarding regulatory and policy requirements.
Apply investigators’ scientific data to protocol documents and associated procedures in accordance with internal and external policies and regulatory requirements.
Participate in other protocol development activities and complete other assignments as warranted and assigned.
Travel as required.