Clinical Research Coord Assoc

Job Summary

Emergency Medicine is looking for an experienced Clinical Research Coordinator to assist with multiple study projects within the Traumatic Brain Injury Program. The candidate will assist with multiple study projects, in all aspects of clinical research including study planning and start‑up, IRB management, identifying study patients, consenting and enrolling participants, lab procedures, as well as data collection. This position may independently provide study coordination for simple and moderately complex clinical research studies.

As a member of a coordination team, this position may help support a portfolio of projects with varying levels of complexity.

Michigan Medicine is firmly committed to advancing inclusion, diversity, equity, accessibility, and belonging, which are core to the culture and values of the Medical School Office of Research. Our community supports recruiting and cultivating a diverse workforce as a reflection of our commitment to serve the diverse people of Michigan and the world. We strive to create a work culture where each team member feels respected, valued, and safe.

• 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
• Responsible for all aspects of research regulatory compliance, such as preparation/writing of IRB protocols for submission and maintenance (including the initial applications, amendments, scheduled continuing reviews, progress reports, safety reports, adverse event reports, etc.), while ensuring effective routine communication with the IRB. Create and maintain study standard operating procedures/protocols and research binders. Perform literature reviews. Completion of study tracking documentation accurately and in a timely manner.
  
  Create and routinely update project tracking systems. Communicate and consult with investigators and study staff to ensure alignment with research protocols and regulatory requirements.
• Responsible for all aspects of research study coordination:
  Identifying/pre‑screening potential subject records to ensure they meet study inclusion criteria, screening potential subjects, consenting and enrollment (using a variety of methods), interviewing subjects, collecting relevant clinical and demographic data, and conducting phone call follow‑up assessments. Coordination of specimen collection and storage. Monitor subjects for safety and compliance with protocols. Coordination/management of all daily study operations.
• May develop, design, and conduct one or more small or moderately complex research projects according to plan; reviews progress and evaluate results. Formulates research methods and suggests options for improving quality, identifies potential problems, recommends, and implements solutions. Consults with study staff to refine or adapt methodologies to fit research goals and specific aims. Collaborates in development of new techniques and procedures/protocols.
• Staff members are expected to work well in a team setting, but also independently when appropriate and regularly exercise good judgment in setting priorities, resolving operational problems, and applying policies, procedures, and methods, while always maintaining the strictest of confidentiality. Regular active participation in research meetings will be expected.
• This position will assist with research studies within the Michigan Medicine Department of Emergency Medicine. Due to the nature of our patient care, this position will routinely require covering some evening and weekend shifts. Cross training with other staff will be required.
• Additional work‑related tasks, not specifically outlined above, will be required of the candidate.

This position reports directly to the Program Manager for the Traumatic Brain Injury Program.

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• Excellent interpersonal, oral, and written communication skills with exceptional attention to detail.
• Must be organized,…