• Independently coordinates complex (i.e. interventional, therapeutic greater than minimal risk) clinical research protocols with minimal direction from the principal investigator and/or supervisor in compliance with regulatory laws and institutional guidelines. 
• Collaborates with research team to assess feasibility and management of research protocols. 
• Ensures implementation of research protocols after IRB approval and provides information as appropriate for progress reports. 
• Screens, enrolls, and recruits research participants. Coordinates schedules and monitors research activities and subject participation. 
• Identifies, reviews, and reports adverse events, protocol deviations, and other unanticipated problems appropriately. 
• Manages, monitors, and reports research data to maintain quality and compliance. 
• Provides education/training for others within the department. 
• Performs administrative and regulatory duties related to the study as appropriate. 
• Some travel may be required. 
• In addition to technical duties above, this position serves as the working supervisor over study coordinators in a program or across multiple programs. 
• Supervisory duties performed will vary based on the percentage of time dedicated to supervision. 
• Protocol Development and Maintenance Activities Responsibilities may include, but are not limited to: ongoing management of the protocol document and process through editing, amendments, proofing, coordination of study logistics (i.e. blood collection kits, data collection booklets, use of CRU, etc.), and verification of content to meet institutional and federal standards; communication with study sites and/or federal agencies regarding study status changes; Federal and Institutional Review Board (IRB) document preparation and submission; and provides consultative expertise regarding regulatory and policy requirements. 
• Accurately applies investigators' scientific data into a cohesive format for the protocol document and associated procedures that are consistent with internal and external policies and regulatory requirements. 
• Participates in other protocol development activities and executes other assignments as warranted and assigned. 

***Visa sponsorship is not available for this position.  This position is not eligible for F-1 OPT STEM extension.***

• HS Diploma with at least 5 years of clinical research coordination/related experience OR 
• Associate's degree/college Diploma/Certificate Program with at least 3 years of experience, Associate's in Clinical Research from an accredited academic institution without experience OR 
• Bachelor's with at least 1 year of experience or completion of a Mayo Clinic-sponsored clinical research internship in lieu of 1 year of experience.
  
  

Additional Qualifications

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