Clinical Research Coordinator- Generalist Pod

Mayo Clinic•Jacksonville, FL

About The Position

Receives direction from a principal investigator, supervisor, or other staff involved in research protocols. Works cooperatively with and provides direction to research staff, collaborates with departments across the institution, and works with investigators and personnel at all levels. Interacts with research participants, other research centers, and sponsoring companies to resolve problems and support efficient completion of studies. Independently coordinates complex clinical research protocols, including interventional and therapeutic protocols greater than minimal risk, with minimal direction. Ensures compliance with regulatory laws and institutional guidelines; collaborates with the research team on protocol feasibility and management; implements protocols after IRB approval; and provides information for progress reports. Screens, recruits, and enrolls participants, coordinates schedules, monitors research activities and participation, identifies and reports adverse events, protocol deviations, and other unanticipated problems, and manages and reports data to maintain quality and compliance. Provides education and training to others and performs related administrative and regulatory duties. Some travel may be required. Protocol development and maintenance duties may include managing protocol documents and processes; editing, amending, and proofing documents; coordinating study logistics; verifying content against institutional and federal standards; 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. Accurately incorporates investigators’ scientific data into protocol documents and procedures consistent with internal and external policies and regulatory requirements. Participates in other protocol development activities and completes other assigned work. This position supports departments including GI, Surgery, Transplant, and Radiology. Visa sponsorship is not available.

Requirements

High school diploma plus at least 5 years of clinical research coordination or related experience; or an associate degree, college diploma, or certificate program plus at least 3 years of experience; or an associate degree in Clinical Research from an accredited academic institution with no experience; or a bachelor’s degree plus 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 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 and in compliance with regulatory laws and institutional guidelines.
Collaborate with the research team to assess protocol feasibility and management.
Ensure protocols are implemented after IRB approval and provide information for progress reports.
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 to 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, including blood collection kits, data collection booklets, and use of the CRU.
Communicate with study sites and federal agencies regarding study status changes.
Prepare and submit federal and IRB documents.
Provide consultative expertise on regulatory and policy requirements.
Incorporate investigators’ scientific data into protocol documents and associated procedures consistent with applicable policies and regulatory requirements.
Work cooperatively with research staff, investigators, research participants, other research centers, and sponsoring companies to resolve problems and support study completion.
Participate in other protocol development activities and perform other assigned work.