A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.
In 2020, the Y-incision aortic annular enlargement (AAE) technique was developed by Dr. Bo Yang at the University of Michigan. This technique has been adopted by many institutions all over the world and has proven to be reproducible. The Y-incision Consortium for Aortic Annular/Root Enlargement (Y-CARE) Registry is an investigator-initiated, international, multi-center, observational registry. At least 25 sites from the United States, Europe, and Asia will be recruited for the registry. The Y-CARE registry will advance clinical knowledge and standards, directly improve patient outcomes, inform lifetime valve disease management, accelerate research and innovation, and enhance global collaboration.
This role will manage the Y-CARE Registry.
This is the entry level position on the Michigan Medicine CRC Career Ladder. This position provides administrative and coordination support for multiple projects in the conduct of clinical research projects. This position may assist with study coordination but will not be assigned clinical trials independently. This position may provide coordination for clinical research projects such as registries, retrospective data reviews, studies in long-term follow-up, and other non-interventional studies.
Knowledge of 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:
Attending and participating in all training classes assigned to this level (Ex: PEERRS, HIPAA, CITI GCP)
Oversee site recruitment at the University of Michigan and participating sites
Manage the REDCap database including, but not limited to, troubleshooting, updates, and access
Data collection, entry, and verification
Adverse event tracking
Update protocol as needed
Manage IRB application including, but not limited to, amendments and study team updates
Maintain regulatory documentation from all participating sites
- Initiate new sites
- Perform other related duties as assigned.
Supervision Received:
This position reports directly to the Clinical Research Manager for the Department of Cardiac Surgery. This position will have functional supervision by Dr. Bo Yang.
Supervision Exercised:
None
High school diploma or GED is necessary.
Bachelor's degree in Health Science or an equivalent combination of related education and experience is desirable.
An understanding of medical terminology, experience in a large complex health care setting, ability to effectively communicate with staff and faculty of all levels, and knowledge of university policies and procedures is desirable.
