Clinical Research Technician​/Assistant

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. Mastery of all job duties from the CRC-Assistant position on the Michigan Medicine CRC Career Ladder is required.

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.

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

Characteristic

Duties and Responsibilities:

Experience as part of a team with 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

We are seeking a motivated clinical research professional who enjoys patient-oriented, collaborative translational science and desires to contribute to research in a team-based environment. The Clinical Research Coordinator will join the clinical research team within the growing Pediatric Diabetes Research Program at the University of Michigan. The clinical Research Coordinator will assist with recruiting, screening, consenting and enrolling research participants in our Pediatric Endocrinology clinics.

The position will also involve in the development of a prospective Type-1 juvenile diabetic patient cohort, coordinating follow-up visits for patients in our longitudinal cohorts, clinical data entry, database management, and training in collection of patient bio specimens and disease activity measures. The principal ongoing project that the Clinical Research Coordinator will work on involves building patient disease registries as part of the industrial research projects led by the PI.

The Clinical Research Coordinator will play a central role in the delivery of high-quality results in the following key responsibilities:

• Identify, screen and enroll potential subjects; consent minimal risk subjects
• Perform data management, such as entering information into Case Report Forms (CRFs)
• Assist with collection of external medical records for study reporting purposes
• Work collaboratively with the CTSU team by maintaining a good rapport and communication with research teams and faculty, as well as patients and families
• Coordination of multicenter study and patient engagement efforts

Collect and manage patient and laboratory data for clinical research subjects.

Collection of patient bio specimens and disease activity measures; maintain oversight to ensure integrity of specimens (collection, shipping/packing, storing, labeling, tracking, etc).

Assist with developing and writing Abstracts/Manuscripts and/or Clinical Trials Protocols.

Support the preparation for IRB audit and monitor:

• Assist in the preparation of IRB applications, amendments and scheduled continuing reviews, progress reports, safety reports and adverse event reports
• In coordination with other CTSU staff, communicate with sponsors concerning progress of clinical research, billing calendar/budget issues, subject related problems, recruitment strategies, and specific policies and procedures
• Act as liaison between study team and sponsors, IRB, federal, state, and University officials and other regulatory agencies to maintain accurate communication of costs, policy changes, fiscal requirements, and other regulatory issues
• Assist in the training of other research staff in the research program

Supervision Received:

This position receives direct supervision and reports directly to (a CRC-Lead, CRC-Project Manager, a unit Administrator, Director, or Faculty Principal Investigator). Functional supervision may be received from the Clinical Research Coordinator Senior in the team.

Supervision Exercised:

None.