Clinical Research Coordinator - Epidemiology

Mayo Clinic; Rochester (MN); Vor Ort; USD 60.000 - 80.000; Teilzeit

Zusammenfassung

The Mayo Clinic in Rochester, MN seeks a clinical research coordinator to independently coordinate complex interventional protocols with minimal direction from the principal investigator. You will collaborate with the research team to assess feasibility, manage logistics, and ensure protocol implementation after IRB approval, while screening, enrolling, and recruiting participants.

Responsibilities include identifying adverse events, managing data quality, and performing regulatory duties with

Qualifikationen

• Experience coordinating complex clinical research protocols
• Regulatory knowledge including IRB submission and approvals
• Ability to manage data quality and compliance
• Education and training of team members in protocol-related procedures

Aufgaben

• Coordinate complex clinical research protocols, including interventional and higher-risk studies, with minimal PI direction.
• Collaborate with the research team to assess feasibility and manage study logistics.
• Ensure protocol implementation after IRB approval and provide information for progress reports.
• Screen, enroll, and recruit participants; schedule and monitor activities.
• Identify, review, and report adverse events and protocol deviations.
• Manage and report research data to maintain quality and compliance.
• Provide education/training to department staff; perform regulatory duties; travel as needed.

Jobbeschreibung

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. 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.

*Please note this position is a 0.70 FTE (56 hours/pay period or every two weeks).

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