Clinical Research Coordinator - Epidemiology

Mayo Clinic • Rochester, MN

3d • $28 - $42

About The Position

The Clinical Research Coordinator independently coordinates complex clinical research protocols, including interventional and therapeutic protocols with greater than minimal risk, with minimal direction from the principal investigator and/or supervisor. The role ensures compliance with regulatory laws and institutional guidelines and collaborates with the research team to assess protocol feasibility and management. After IRB approval, the coordinator implements protocols, provides information for progress reports, screens, enrolls, and recruits participants, coordinates schedules, monitors research activities and participant involvement, and manages research data to maintain quality and compliance. The coordinator also identifies, reviews, and reports adverse events, protocol deviations, and other unanticipated problems, provides departmental education and training, and performs study-related administrative and regulatory duties. Some travel may be required.

Protocol development and maintenance work may include managing protocol documents and processes through editing, amendments, proofing, coordinating study logistics, 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; provide consultative expertise on regulatory and policy requirements; accurately incorporate investigators’ scientific data into protocol documents and procedures consistent with internal and external requirements; and undertake other protocol development activities and assignments. The position is 0.70 FTE, or 56 hours per pay period (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, or 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, which may be replaced by completion of a Mayo Clinic-sponsored clinical research internship.
• Experience must 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

• Independently coordinate complex clinical research protocols with minimal direction from the principal investigator and/or supervisor, in compliance with regulatory laws and institutional guidelines.
• Collaborate with the research team to assess protocol feasibility and management.
• Implement research protocols after IRB approval and provide information as appropriate for progress reports.
• Screen, enroll, and recruit research participants.
• Coordinate schedules and monitor research activities and participant participation.
• Identify, review, and appropriately report adverse events, protocol deviations, and other unanticipated problems.
• Manage, monitor, and report research data to maintain quality and compliance.
• Provide education and training for others within the department.
• Perform administrative and regulatory duties related to studies as appropriate.
• Manage protocol documents and processes, including editing, amendments, proofing, logistics coordination, and content verification against institutional and federal standards.
• Communicate with study sites and/or federal agencies regarding study status changes.
• Prepare and submit federal and IRB documents.
• Provide consultative expertise regarding regulatory and policy requirements.
• Accurately apply investigators’ scientific data to protocol documents and associated procedures consistent with internal and external policies and regulatory requirements.
• Participate in other protocol development activities and perform other assignments as warranted and assigned.
• Travel as required.

Benefits

• Multiple medical plan options.
• Dental coverage through Delta Dental or a reimbursement account for flexible coverage.
• Affordable vision plan with a national network.
• HSA and FSAs for eligible expenses.
• Competitive retirement package.
• Continuing education and advancement opportunities.
• Competitive compensation and comprehensive benefit plans.

What This Job Offers

• Job Type: Part-time
• Career Level: Mid Level
• Education Level: High school or GED