Clinical Research Assistant, Ann Arbor

Y-Care Registry Manager

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-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.Responsibilities*

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 ProfessionalismCommunication 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 accessData 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 Required Qualifications*

High school diploma or GED is necessary. Desired Qualifications*

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.Knowledge of cardiovascular physiology, specifically concerning the aorta and aortic valve Experience with REDCap Why Join Michigan Medicine?

Michigan Medicine is one of the largest health care complexes in the world and has been the site of many groundbreaking medical and technological advancements since the opening of the U-M Medical School in 1850. Michigan Medicine is comprised of over 30,000 employees and our vision is to attract, inspire, and develop outstanding people in medicine, sciences, and healthcare to become one of the world’s most distinguished academic health systems. In some way, great or small, every person here helps to advance this world-class institution. Work at Michigan Medicine and become a victor for the greater good.What Benefits can you Look Forward to? Excellent medical, dental and vision coverage effective on your very first day 2:1 Match on retirement savings Work Schedule

Hours/Week: 40 hours Shift/Hours/Days: Days, occasional evening, potential weekends U-M EEO Statement

The University of Michigan is an equal employment opportunity employer.