Clinical Research Coordinator - Alzheimer's Disease Research

Mayo Clinic•Rochester, MN
•$28 - $42

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. Ensures compliance with regulatory laws and institutional guidelines; collaborates with the research team to assess protocol feasibility and management; implements protocols following IRB approval; and provides information for progress reports as appropriate. 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 study data to maintain quality and compliance. Provides departmental education and training and performs study-related administrative and regulatory duties. Some travel may be required. Protocol development and maintenance duties may include managing protocol documents and processes through editing, amendments, proofing, and content verification; 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 IRB documents; and providing consultative expertise on regulatory and policy requirements. Accurately incorporates investigators’ scientific data into protocol documents and associated procedures consistent with internal and external policies and regulatory requirements. Participates in other protocol-development activities and completes other assignments as warranted. Cognitive testing is a required part of the position. Prior experience is not required, but the coordinator should be comfortable learning to administer standardized cognitive assessments as a regular responsibility. Visa sponsorship is unavailable, and the position is not eligible for the F-1 OPT STEM extension.

Requirements

  • Qualifying education and experience: high school diploma with at least 5 years of clinical research coordination or related experience; associate degree, college diploma, or certificate program with at least 3 years of experience; associate degree in Clinical Research from an accredited academic institution with no experience required; or 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 must be in a clinical setting or a related area.
  • Strong clinical trial background, including experience with clinical trial coordination and study conduct.
  • Comfort learning to administer standardized cognitive assessments.
  • Some travel may be required.

Nice To Haves

  • 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, ensuring 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 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/or federal agencies regarding study status changes.
  • Prepare and submit federal and institutional IRB documents.
  • Provide consultative expertise regarding regulatory and policy requirements.
  • Incorporate investigators’ scientific data into protocol documents and procedures consistent with internal and external policies and regulatory requirements.
  • Administer standardized cognitive assessments after learning the required procedures.
  • Travel as required.

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 for eligible expenses.
  • Competitive retirement package.
  • Competitive compensation and comprehensive benefit plans.
  • Continuing education and advancement opportunities.
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