Clinical Research Coord Assoc

Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally. Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society.

The REMEDY team at the University of Michigan (UM) manages the vast portfolio of surgical clinical trials for the Department of Cardiac Surgery. The team consists of varying levels of coordinators dedicated to advancing healthcare to improve outcomes for patients. Our collaborators include investigators from other departments within UM, industries, and Universities. We specialize in multi-center, including international, device trials as well as outcomes research, drug trials, and investigator-initiated studies.

As we continue to expand our portfolio, we are looking for detail orientated, highly motivated, compassionate individuals to join our team.

This clinical research coordinator (CRC) position may provide study coordination for multiple clinical research studies depending on complexity that range from moderate to complex. Coordinator experience and mastery of all job duties from the CRC-Technician position on the Michigan Medicine CRC Career Ladder is required. This position should be able to perform tasks and make decisions independently, consistently, and accurately, and demonstrate that they have achieved a moderate level of expertise in all their skills and abilities resulting in high quality work.

It is presumed that this position is able to apply their skills to a broad range of different types of clinical studies, navigate available resources appropriately, effectively use all tools and job aids at their disposal and operate e-clinical technologies with a reasonable degree of proficiency. This position can perform the majority of tasks independently and perform quality checks of their work.

They also know where and how to identify appropriate resources and support and are able to discern when to elevate issues needing additional intervention. Key behavioral competency descriptors include demonstrate, implement, execute, and use.

Independent knowledge, skills, and abilities within all 8 competency domains is expected:

• 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

• Understanding of protocol elements/requirements
• Executing study procedures
• Anticipating and mitigating the potential for protocol non-compliance
• Accurate implementation of protocol procedures
• Describing and performing routine study management activities
• Performing study procedures with minimal supervision
• Triaging routine participant concerns and issues appropriately
• Scheduling, assisting with preparation, and attending study-related meetings (e.g. study initiation meetings, audits, monitoring visits, or community-based organizational meetings)
• Participating in regular study meetings
• Properly completing payment forms and pays participants accordingly
• Serving as primary point of contact for study and/or a study team
• Documenting data in accordance with ALCOA-C principles and/or the study data management plan
• Completing complex data collection during study visits
• Resolving data queries
• Appropriately identifying and reporting adverse events (AEs), Serious Adverse Events (SAEs), and Other Reportable Information and Occurrences (ORIOs)
• Maintaining essential documents as outlined in the GCP guidelines, or other relevant guidelines.
• Other related duties as assigned.

This position reports directly to the Clinical Trial Lead for the Department of Cardiac Surgery.

None.

• 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…