Clinical Research Coordinator - Epidemiology

Mayo Clinic • Rochester, MN

3d • $28 - $42

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. Ensures compliance with regulatory laws and institutional guidelines, collaborates with the research team to assess protocol feasibility and management, and implements protocols following IRB approval. Screens, recruits, and enrolls participants; coordinates schedules and monitors research activities and participant involvement; and identifies, reviews, and reports adverse events, protocol deviations, and other unanticipated problems. Manages, monitors, and reports research data to maintain quality and compliance, provides departmental education and training, and performs administrative and regulatory study duties. Some travel may be required.

Protocol development and maintenance work 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 accurately incorporates investigators’ scientific data into cohesive protocol documents and associated procedures consistent with internal and external policies and regulatory requirements, participates in other protocol development activities, and performs other assignments as warranted.

Requirements

• High school diploma and at least 5 years of clinical research coordination or related experience; or an associate’s degree, college diploma, or certificate program and at least 3 years of experience; or an associate’s 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 related experience.

Nice To Haves

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

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 as appropriate.
• Screen, recruit, and enroll 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 administrative and regulatory duties related to studies.
• 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 against 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.
• Accurately incorporate investigators’ scientific data into 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.
• Travel may be required.

Benefits

• Medical plan options
• Dental coverage through Delta Dental or a reimbursement account for flexible coverage
• Vision plan with a national network
• HSA and FSAs for eligible expenses
• Competitive retirement package
• Continuing education and advancement opportunities

What This Job Offers

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