Clinical Research Coordinator - GIH

Mayo Clinic•Phoenix, AZ

3h•Onsite

About The Position

We are seeking a highly motivated Clinical Research Coordinator to join our team in an esophageal dedicated role. This position will be 100% dedicated to the Department of Gastroenterology and Hepatology, supporting a dynamic and growing portfolio of early-phase and novel clinical trials. As a high-impact contributor, the coordinator will play a critical role in advancing esophageal research by managing multiple studies from initiation through close-out. The ideal candidate will thrive in a fast paced, collaborative environment and demonstrate a strong commitment to clinical excellence and research integrity. 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.

Requirements

Thrive in a fast paced, collaborative environment
Demonstrate a strong commitment to clinical excellence and research integrity

Nice To Haves

Prior experience supporting GI research

Responsibilities

Manage multiple studies from initiation through close-out
Independently coordinate 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
Collaborate with research team to assess feasibility and management of research protocols
Ensure implementation of research protocols after IRB approval and provide information as appropriate for progress reports
Screen, enroll, and recruit research participants
Coordinate schedules and monitor research activities and subject participation
Identify, review, and report adverse events, protocol deviations, and other unanticipated problems appropriately
Manage, monitor, and report research data to maintain quality and compliance
Provide education/training for others within the department
Perform administrative and regulatory duties related to the study as appropriate
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
Provide consultative expertise regarding regulatory and policy requirements
Accurately apply 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
Participate in other protocol development activities and execute other assignments as warranted and assigned