Clinical Research Coordinator Associate

About This Role

This Clinical Research Coordinator (CRC) position provides study coordination for multiple clinical research studies, ranging from moderate to complex. The role requires prior coordinator experience and mastery of all duties from the CRC-Technician position on the Michigan Medicine CRC Career Ladder. This position involves performing tasks and making decisions independently, consistently, and accurately, demonstrating a moderate level of expertise in all skills and abilities to produce high-quality work.

Responsibilities

• Directly interact with clinical research participants, as required, for the research study (non-clinical and clinical procedures) via telephone, telehealth, or in-person
• Coordinate regulatory documentation for research studies, including maintaining information to comply with industry standards, University policies, FDA requirements, or other hospital policies
• Coordinate and schedule procedures as per research study
• Pend study order sets with oversight by PI (for non-licensed coordinators)
• Screen, recruit, enroll, and follow subjects according to research protocol guidelines (non-clinical and clinical procedures)
• Assist with the consent processes
• Maintain and coordinate data collection information required for each study, which may include developing CRFs (case report forms) or data collection tools
• Assist in developing and implementing research studies, which may include writing clinical research protocols
• Conduct research procedures according to the protocol with proper training and check-offs to maintain scope of service
• Assist the PI on the fiscal management of the trial, including budget preparation
• Monitor patient safety by reviewing records and ensuring appropriate reporting per protocol and HRPP standards
• Perform research billing activities, as needed, based on department size (including linking patient calendars)
• Coordinate data management and collection for national (larger/more complex) research studies or multiple research studies at a given time
• Serve as primary liaison/lead in preparing annual reports for federal, state, and/or local agencies on assigned studies
• Prepare protocols for Institutional Review Board (IRB) submission
• Submit amendments and continuing review documents
• Provide in-service training to all study team members and communicate to involved groups
• Review research study protocols to ensure feasibility requirements of the study
• Assist in developing a website or other social media for marketing/recruiting based on assigned clinical research

Requirements

• Coordinator experience and mastery of all job duties from the CRC-Technician position on the Michigan Medicine CRC Career Ladder