Clincal Research Coordinator - Technician

Responsibilities Characteristic Duties and Responsibilities Scientific Concepts and Research Design Ethical Participant Safety Considerations Investigational Products Development and Regulation Clinical Study Operations (GCPs) Study and Site Management Data Management and Informatics Leadership and Professionalism Communication and Teamwork Clinical Research Coordinator Tasks Assist study team with identifying potential subjects, screening, consenting and enrolling subjects, and collecting and managing patient and laboratory data. Collect specimens and monitor study subjects; assist in monitoring of test results; ensure integrity of specimens (collection, processing, shipping, packing, storing, labeling, tracking). Perform data management and results reporting, entering information into Case Report Forms (CRFs); assist with external medical records; identify and report Adverse Events (AEs) and Serious Adverse Events (SAEs). Prepare IRB submissions including initial applications, amendments, scheduled continuing reviews, progress reports, safety reports, and adverse event reports. Coordinate with other M-CTSU staff and sponsors concerning progress of clinical trials, billing and budget issues, recruitment strategies, and policies. Act as liaison between study team and sponsors, IRB, federal, state, and university officials, and other regulatory agencies; serve as key resource to participants and collaborators; provide support for audits and monitoring visits. Work collaboratively with the M-CTSU team, research teams, faculty, patients, and families. Prepare and organize space for study-related materials and equipment. Traverse the medical campus, transport and position clinical research supplies weighing up to 50 pounds. Work independently, exercising good judgment in setting priorities, resolving operational problems, and applying policies and procedures while maintaining confidentiality. Help mentor and train other CRC staff through formal and informal presentations. Perform other administrative responsibilities as assigned. Supervision This position receives direct supervision and reports directly to the unit Administrator, CRC-Lead, or CRC-Project Manager. None. Required Qualifications Associate's Degree or equivalent in combined education and clinical research experience Minimum of 1+ years direct related experience OR advanced degree in health‑related areas OR 3 years of related human subjects experience Underfill Requirements High School Diploma or GED Desired Qualifications Bachelor's Degree in Health Science or an equivalent combination of related education and experience is desirable An understanding of medical terminology is preferred Knowledge of Michigan Medicine policies and practice Familiarity with OnCore, Epic, MiCHART, and eResearch applications PEERS, CITI, or NIH Protection of Human Subjects Training Certification Experience with local and central IRB application processes Work Information Positions that are eligible for hybrid or mobile/remote work mode are at the discretion of the hiring department. Work agreements are reviewed annually at a minimum and are subject to change at any time. This position will primarily work Monday through Friday during normal business hours. This position may be underfilled at the CRC‑Assistant (103921) title based on selected candidates' qualifications. EEO Statement The University of Michigan is an equal employment opportunity employer. #J-18808-Ljbffr