How to Apply
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.
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
- 2:1 Match on retirement savings
This position has oversight for clinical research trials within the Department of Cardiology and has responsibility for ensuring that they are completed within specifications. This individual will work to establish operational objectives and assignments for their own studies as well as work with other clinical research coordinators within the Department. Primary activities and decision making authority are predominantly performed independently affecting business operations to a substantial degree. Under FLSA, incumbents in this position meet the criteria for exempt status. Additional duties of the position include:
- Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study specific manuals and procedures under the supervision of the Program Manager, PI and CO-I.
- Screen and recruit study subjects from clinic, schedule follow-up appointments, complete study assessments, educate patients and physicians regarding the specifics of each study.
- Assist PI’s in reviewing progress of the studies and evaluating results.
- Maintain databases for research studies.
- Analyze, compare and evaluate various courses of action for clinical research studies.
- Monitor trial by reviewing and reporting on the following: site enrollment and termination updates, monitor protocol deviation/exceptions, serious adverse events and work with IRB coordinator to report AEs/SAEs, amendments, continuing reviews, etc.
- Write, edit, and renew IRB applications for clinical trials.
- Bachelor's degree in health science or health related field, or equivalent education and experience.
- Prefer at least two years of direct clinical research experience.
- Excellent written and oral communication skills.
- Working knowledge of Good Clinical Practice (GCP), FDA regulations and Code of Federal Regulatons (CFR); in addition, experience with the IRB application process and understanding of medical terminology.
- Strong leadership and interpersonal skills with attention to detail.
- Exceptional organizational skills.
- Must be able to meet multiple concurrent deadlines.
- Demonstrate project management ability, work well in a team setting as well as independently with the ability to exercise good judgment in setting priorities, resolving problems, applying policies and procedures, while maintaining confidentiality at all times.
- Proficient in health/clinical research related terminology, management of regulatory documents including institutional review board (IRB) submissions, adverse event reporting, quality assurance, data query resolution, understanding of compliance issues with regard to human subject research.
- Proficiency in computer skills, including Microsoft software applications as well as electronic databases.
- Clinical research experience.
- Certification through ACRP or SoCRA.
- Familiarity with Epic, MiChart, eResearch and OnCore.
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.
U-M COVID-19 Vaccination Policy
COVID-19 vaccinations are now required for all University of Michigan students, faculty and staff across all three campuses, including Michigan Medicine, by the start of the fall term on August 30, 2021. This includes those working or learning remotely. More information on this policy is available on the Campus Blueprint website or the U-M Dearborn and U-M Flint websites.