Initiate, conduct and manage complex clinical research studies including patient screening and enrollment; study medication accountability and distribution; timely data entry; coordination of study visits, labs and procedures; accurate documentation; and communication with physicians, study coordinators and sponsors.
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.
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
- Retirement Savings Opportunities
Other job responsibilities include:
- Meticulous conduct of both interventional and observational clinical research studies.
- Ability to integrate workflow for multiple studies running simultaneously.
- Accurate preparation and maintenance of IRB and other regulatory documents.
- Creation and maintenance of source documents for accurate tracking, collection and recording of experimental data
- Serve as a resource and contact person for active protocols.
- Assist with study initiation including critique of study protocol and assistance with billing calendar and budget preparation.
- Attendance at educational, investigator and coordinator meetings
- Maintenance of training, education and knowledge regarding conduct of clinical research in accordance with federal and ICH GCP.
- Paid on call for evenings, nights, weekends and holidays is a requirement to be shared with co-workers.
- Minimum Undergraduate degree required (e.g. BS, BA, BE, etc), preferably in a health related field of study.
- 2 or more years of clinical research experience
- Candidate who desires patient focused, team oriented, medically complex, scientifically interesting, intellectually stimulating fast paced work environment!
- Familiarity with MS Word and Excel.
- Experience with IRB applications.
- Experience working with electronic medical records.
- Experience in regulatory aspects of medical research and policy/procedures in the conduct of clinical trials both at an institutional and federal level.
- Excellent verbal and writing skills.
- Knowledge of ICH Good Clinical Practice (GCP) Guidelines. Knowledge of transplant terminology.
- Must be able to interact effectively with patients, faculty, staff, patients and others. Team work is a critical component of this position.
- Ability to work independently while maintaining excellent organizational and interpersonal skills. NIH certification-Human subjects.
- Desire to work in a fast-paced, patient oriented environment to further scientific knowledge.
- 2-3 years experience in clinical trial coordination.
- Experience with REDCap, iMedidata, or other data entry platforms.
- Ability to collect/process lab specimens.
- SOCRA or ACRP certification within first year of hire.
- Registered Nurse with current State of Michigan License or graduate of Clinical Research Administration.
- Normal work schedule is 8-4:30 pm Monday through Friday. Shared flexibility in daily/weekly work schedule required due to transplants timing.
- Required evening, night, weekend and holiday on call shared by multiple research coordinators.
Michigan Medicine conducts background screening and pre-employment drug testing on job candidates upon acceptance of a contingent job offer and may use a third party administrator to conduct background screenings. Background screenings are performed in compliance with the Fair Credit Report Act. Pre-employment drug testing applies to all selected candidates, including new or additional faculty and staff appointments, as well as transfers from other U-M campuses.
Job openings are posted for a minimum of seven calendar days. The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled anytime after the minimum posting period has ended.
U-M EEO/AA Statement
The University of Michigan is an equal opportunity/affirmative action employer.