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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.

Job Summary

In collaboration with the MCTSU, Assistant Director of Inpatient Research, the Clinical Research Study Coordinator will provide a value added service assisting inpatient faculty with study coordination of any clinical trials within the MCTSU as needed. This position will be part of a study coordinator pool providing support to junior faculty as well as established study teams for clinical trials. The coordinator will be available to assist study teams with study coordinator activities such as screening, collecting and managing patients and laboratory data for clinical research subjects, data entry, and regulatory management. Additionally, the research coordinator will assist, if needed in preparation of IRB submissions, billing calendars, and other related duties as needed.

Mission Statement

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

Responsibilities*

  • Assist with aspects of inpatient trial coordination including screening, collecting and managing patients and laboratory data for clinical research subjects.
  • Prepare IRB submissions including initial as well as scheduled continuing reviews, progress reports, adverse event and ORIO reports and become subject matter experts for both local and external IRB submissions.
  • Work collaboratively with the MCTSU finance team providing consultation on budget specifications and billing calendar creation, collaborate on post-award account reconciliation and close out.
  • Provide support for FDA audits.
  • Support other clinical research staff across the inpatient realm in study coordination activities during ‘off hours’ and weekends.
  • This position should be able to perform tasks independently, consistently, and accurately, and demonstrate that they have achieved a moderate level of expertise in all of their skills and abilities resulting in high quality work. It is presumed that this position is able to apply their skills to a broad range of different types of clinical studies, navigate available resources appropriately, effectively use all tools and job aids at their disposal and operate e-clinical technologies with a reasonable degree of proficiency. This position can perform the majority of tasks independently and perform quality checks of their work. They also know where and how to identify appropriate resources and support and are able to discern when to escalate issues needing additional intervention.

Required Qualifications*

  • Bachelor degree in a science or health-related field or equivalent education and experience and over 1 year minimum experience as a study coordinator or study monitor.
  • Demonstrated knowledge of medical terminology.
  • Ability to work independently with minimal supervision and with diverse teams of people in a diplomatic, collaborative and effective manner.
  • Ability to work varied work hours. This position requires weekend work.
  • Excellent interpersonal, oral, and written communication skills with exceptional attention to detail.
  • Excellent computer skills including proficiency in Microsoft software applications.
  • Excellent organizational skills including the ability to multi-task and work well under time constraints and deadlines.
  • Experience and understanding of start-up process related to clinical trials.
  • Certification through ACRP or SoCRA or willingness to become certified.

Desired Qualifications*

  • Demonstrated knowledge of medical terminology specifically related to acute care.
  • Familiarity with UM Systems such as OnCore, MiChart (Epic) and eResearch applications.
  • Experience with IRB application process.
  • Demonstrated understanding of clinical research; understand compliance issues related to human subject research, knowledge and application of the Code of Federal Regulations (CFR), Good Clinical Practice (GCP), and FDA regulations.
  • PEERS, CITI or NIH Protection of Human Subjects Training Certification.

Work Locations

Days of work include: primarily Monday through Friday, Day Shift with weekend coverage shared with others in the coordinator pool.

Variability/flexibility will be required. Ability to work both from home and on site will be required.
 

Background Screening

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.

Application Deadline

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.