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 the research team to assess protocol feasibility and management.

The coordinator implements protocols after IRB approval; supports progress reporting; screens, recruits, and enrolls participants; coordinates schedules; and monitors research activities and participant involvement. The role identifies, reviews, and reports adverse events, protocol deviations, and other unanticipated problems, and manages, monitors, and reports research data to maintain quality and compliance. It also provides education and training to departmental staff and performs administrative and regulatory study duties. Some travel may be required.

Protocol development and maintenance responsibilities may include managing protocol documents and processes through editing, amendments, proofing, and verification against institutional and federal standards; coordinating study logistics; communicating with study sites or federal agencies about study status changes; preparing and submitting federal and IRB documents; and providing consultative expertise on regulatory and policy requirements. The coordinator accurately incorporates investigators’ scientific data into protocol documents and related procedures in accordance with internal and external policies and regulatory requirements, and may take on other protocol development assignments.

The position supports various departments, including GI, Surgery, Transplant, and Radiology. Mayo Clinic states that visa sponsorship is not available for this position.

Requirements

• High school diploma with at least 5 years of clinical research coordination or related experience; or an associate degree, college diploma, or certificate program with 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 with 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.
• Ability to coordinate complex clinical research protocols and comply with regulatory laws and institutional guidelines.

Nice To Haves

• Patient care experience.
• Clinical research experience.
• 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, 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 for progress reports as appropriate.
• Screen, recruit, and enroll research participants.
• Coordinate schedules and monitor research activities and participant involvement.
• 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 for others within the department.
• Perform administrative and regulatory duties related to studies.
• Manage protocol documents and processes, including editing, amendments, proofing, and verification against institutional and federal standards.
• Coordinate study logistics, such as blood collection kits, data collection booklets, and use of the CRU.
• Communicate with study sites 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 assigned duties.
• Collaborate with research staff, institutional departments, investigators, research participants, other research centers, and sponsoring companies to resolve problems and support efficient study completion.

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 FSA pre-tax savings accounts for eligible expenses.
• Competitive retirement package.
• Competitive compensation and comprehensive benefit plans.
• Continuing education and advancement opportunities.

What This Job Offers

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