Clinical Research Coordinator- Generalist Pod

Mayo Clinic • Jacksonville, FL

2d • $28 - $42

About The Position

The Clinical Research Coordinator independently coordinates complex clinical research protocols, including interventional and therapeutic studies greater than minimal risk, with minimal direction from the principal investigator or supervisor. The role ensures compliance with regulatory laws and institutional guidelines and collaborates with research teams to assess protocol feasibility and management.

The coordinator implements studies after IRB approval; recruits, screens, and enrolls participants; coordinates schedules and monitors research activities and participation; identifies and reports adverse events, protocol deviations, and other unanticipated problems; and manages, monitors, and reports research data to support quality and compliance. The role also provides education and training to departmental staff and performs study-related administrative and regulatory duties. Some travel may be required.

Protocol development and maintenance may include managing and editing protocol documents and amendments, proofing, coordinating study logistics, verifying content against institutional and federal standards, communicating with study sites or federal agencies about status changes, preparing and submitting federal and IRB documentation, and advising on regulatory and policy requirements. The coordinator applies investigators' scientific data to protocol documents and procedures in accordance with applicable policies and requirements, and performs other protocol-development assignments as needed. This position supports departments including GI, Surgery, Transplant, and Radiology. Visa sponsorship is not available.

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 be related experience.

Nice To Haves

• Patient care experience.
• Clinical research experience.
• Graduate or diploma completion 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 while complying with regulatory laws and institutional guidelines.
• Collaborate with research teams to assess the feasibility and management of research protocols.
• Implement 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 involvement.
• 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 to others within the department.
• Perform administrative and regulatory duties related to studies.
• Manage protocol documents and processes, including editing, amendments, proofing, logistics coordination, and verification against institutional and federal standards.
• Communicate with study sites and/or federal agencies about study status changes.
• Prepare and submit federal and Institutional Review Board documentation.
• Provide consultative expertise on regulatory and policy requirements.
• Apply investigators' scientific data to protocol documents and associated procedures in accordance with internal and external policies and regulatory requirements.
• Perform other protocol-development activities and assignments as warranted.

Benefits

• Multiple 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: Full-time
• Career Level: Mid Level
• Education Level: High school or GED