University of Michigan Information and Technology Services · 9 hours ago
Clinical Research Coordinator Intermediate
Ann Arbor, MI
Full-time
Hybrid
Mid, Senior Level
3+ years expThe University of Michigan Information and Technology Services is seeking a Clinical Research Coordinator Intermediate to provide study coordination for multiple clinical research studies. The role involves assisting study teams, ensuring participant safety, managing data, and preparing IRB submissions while contributing to the development of new processes and tools to enhance clinical research activities.
Information Technology & Services
Responsibilities
Assist study team with aspects of clinical research coordination including identifying potential subjects, screening subjects, consenting and enrolling subjects, and collecting and managing patient and laboratory data for clinical research subjects
Collect specimens and monitor study subjects. Assist in monitoring of test results. Ensure integrity of specimens (collection, processing, shipping/packing, storing, labeling, tracking, etc.)
Perform data management and results reporting, such as entering information into Case Report Forms (CRFs). Assist with collection of external medical records for study reporting purposes. Ability to identify and report Adverse Events (AEs) and Serious Adverse Events (SAEs)
Prepare IRB submissions including the initial applications, as well as amendments and scheduled continuing reviews, progress reports, safety reports, and adverse event reports
In coordination with other M-CTSU staff, communicate with sponsors concerning progress of clinical trials, billing calendar/budget issues, subject related problems, recruitment strategies, and specific policies and procedures
Act as liaison between study team and sponsors, IRB, federal, state, and university officials and other regulatory agencies to maintain accurate communication of costs, policy changes, fiscal requirements, and other regulatory issues. Serve as key resource to research participants and collaborators. Provide support for audits and monitor visits
Work collaboratively with the M-CTSU team by maintaining a good rapport and communication with research teams and faculty, as well as patients and families
Prepare and organize space for study related materials and equipment
Staff members are expected to work independently and regularly exercise good judgment in setting priorities, resolving operational problems, and applying policies, procedures, and methods, while always maintaining the strictest of confidentiality
This person may help mentor and train other CRC staff through formal and informal presentations
Qualification
Required
Bachelor's degree in Health Science or an equivalent combination of related education and experience is necessary
Certification is required through Association of Clinical Research Professionals (ACRP) as a Certified Clinical Research Coordinator (CCRC) or Society of Clinical Research Association (SOCRA) as a Certified Clinical Research Professionals (CCRP) or equivalent. Candidates must be eligible to register or take the exam at date of hire and the certification must be completed or passed etc. within six months of date of hire. (Please review eligibility criteria from SoCRA or ACRP prior to applying.)
Minimum 3 years of directly related experience in clinical research and clinical trials is necessary. (Please review SoCRA?s Definition of a Clinical Research Professional for qualifying experience prior to applying.)
Preferred
6+ years of direct related experience
Company
University of Michigan Information and Technology Services
We are 700+ professionals supporting the U-M community of over 47,000 students, 6200 faculty and researchers, 25,000 staff, and a worldwide network of alumni and retirees.
501-1000 employees
Funding
Current Stage
Late StageLeadership Team
Michelle Durante, PHR
Senior HR Business Partner
Sol Bermann
Chief Information Security Officer & Executive Director, Information Assurance
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