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 escalate 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
Responsibilities will include, but are not limited to:
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.
