About The Position

The Associate Clinical Research Coordinator receives direction from the principal investigator, supervisor, or other staff involved in research protocols. The role interacts with institutional departments, investigators and personnel at all levels, research participants, other research centers, and sponsoring companies to resolve problems and support efficient completion of research studies. The coordinator manages non-therapeutic, minimal-risk clinical research protocols, including surveys and chart reviews, under direction and in compliance with regulatory laws and institutional guidelines. The position may assist with complex interventional, therapeutic, or greater-than-minimal-risk studies but does not have overall responsibility for them. Some travel may be required. The role is based at the Mayo Clinic Florida site; visa sponsorship and relocation are not available. When assigned protocol development and maintenance activities, responsibilities may include managing protocol documents and processes through editing, amendments, proofing, coordinating study logistics, and verifying content against institutional and federal standards. Duties may also include Institutional Review Board submissions and communicating with study sites or federal agencies about study status changes. The coordinator may participate in other protocol development activities and complete other assignments as warranted.

Requirements

  • One of the following education and experience combinations: high school diploma with at least 3 years of experience; associate's degree/college diploma/certificate program with at least 1 year of experience; associate's degree in clinical research from an accredited academic institution with no experience; or bachelor's degree.
  • Experience should be in a clinical setting or related experience.

Nice To Haves

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

Responsibilities

  • Coordinate non-therapeutic, minimal-risk clinical research protocols under the direction of the principal investigator and/or supervisor and in compliance with regulatory laws and institutional guidelines.
  • Assist with complex interventional, therapeutic, or greater-than-minimal-risk studies under direction, without overall responsibility for those studies.
  • Screen, enroll, and recruit research participants.
  • Coordinate schedules and monitor research activities and subject participation.
  • Recognize adverse events, protocol deviations, and other unanticipated problems, and report them appropriately.
  • Collect, abstract, and enter research data.
  • Perform assigned administrative and regulatory duties related to studies.
  • Manage protocol documents and processes, including editing, amendments, proofing, coordinating study logistics, and verifying content against institutional and federal standards, as assigned.
  • Submit materials to the Institutional Review Board and communicate with study sites and/or federal agencies regarding study status changes, as assigned.
  • Participate in other protocol development activities and complete other assignments as warranted.
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