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. The coordinator works in compliance with regulatory laws and institutional guidelines, collaborates with the research team to assess protocol feasibility and management, and implements protocols following IRB approval. The role screens, enrolls, and recruits participants; coordinates schedules and monitors research activities and participant involvement; identifies, reviews, and reports adverse events, protocol deviations, and other unanticipated problems; and manages, monitors, and reports research data to maintain quality and compliance. The coordinator also provides education and training to others in the department and performs study-related administrative and regulatory duties. Some travel may be required. Protocol development and maintenance activities may include managing protocol documents and processes through editing, amendments, proofing, and verification that content meets institutional and federal standards; coordinating study logistics such as blood collection kits, data collection booklets, and use of the CRU; communicating with study sites and/or federal agencies about study-status changes; preparing and submitting Federal and Institutional Review Board (IRB) documents; and providing consultative expertise on regulatory and policy requirements. The coordinator accurately applies investigators’ scientific data to cohesive protocol documents and associated procedures consistent with internal and external policies and regulatory requirements, participates in other protocol development activities, and carries out other assigned duties. This position is 0.80 FTE, or 64 hours per pay period (every two weeks). Visa sponsorship is unavailable, and the position is not eligible for the F-1 OPT STEM extension.

Requirements

  • High school diploma and at least 5 years of clinical research coordination or related experience; or an associate degree/college diploma/certificate program and 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 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 a related area.

Nice To Haves

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

Responsibilities

  • 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.
  • Implement research protocols after IRB approval and provide information for progress reports as appropriate.
  • Screen, enroll, and recruit research participants.
  • Coordinate schedules and monitor research activities and participant participation.
  • 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, and verifying content 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/or federal agencies regarding study-status changes.
  • Prepare and submit Federal and Institutional Review Board (IRB) documents.
  • Provide consultative expertise regarding regulatory and policy requirements.
  • Apply investigators’ scientific data to 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.

Benefits

  • Medical plan options.
  • Dental coverage through Delta Dental or a reimbursement account for flexible coverage.
  • Vision plan with a national network.
  • Health Savings Account (HSA) and Flexible Spending Accounts (FSAs) for eligible expenses.
  • Competitive retirement package.
  • Competitive compensation and comprehensive benefit plans.
  • Continuing education and advancement opportunities.
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