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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

The Clinical Trials Support Office (CTSO) is part of Michigan Medicine’s strategic research initiative working towards improving clinical care, value, and health outcomes by successfully executing a diverse portfolio of high-quality clinical research. The CTSO provides the organizational structure of local service units, central infrastructure, and governance oversight. Within the CTSO, Clinical Trials Support Units (CTSUs) aligned by research foci, are trans-departmental and provide comprehensive pre- and post-award support to study teams, offering high-quality, efficient service in support of a wide variety of clinical research.

The CTSO helps life-changing research happen. The science we support is not only interesting, but it also has the very real potential to positively impact patients and their families. We are looking for a candidate who embraces their supporting role in pushing these scientific advancements forward. If you are a study coordinator looking to take your career to the next level, this position is for you. The CTSO is a relatively new organizational model. You’ll have the flexibility to impact the entire team as our unit expands its mission to support clinical research. Creative problem-solving skills are strongly encouraged.

In collaboration with the CTSU Medical Directors and Associate Director of Operations, this position is responsible for developing, enhancing and managing the clinical trials serviced by the CTSU. Supervise the day-to-day research and protocol specific activities associated with the Children's CTSU as it pertains to participation in clinical research studies.

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
  • 2:1 Match on retirement savings

Responsibilities*

Manage the day-to-day operations of clinical trials (in aggregate) related to study activation, conduct and closeout. Responsibilities include, but are not limited to:

  • Serve as an initial point of contact for new studies;
  •  Process intake forms and unfunded agreements;
  • Correspond with sponsors to obtain trial information and required documents to initiate the activation process;
  • Monitor the status of start-up timelines for new studies including IRB approval, budget development and contract execution;
  • Coordinate with other CTSUs and ancillary units as appropriate (i.e. ORSP, CRAO, IDS, MCRU);
  •  Coordinate CTSU feasibility review for new studies including staffing and budgetary requirements, clinical and logistical considerations, and competing studies;Facilitate billing calendar review and updates; Lead study planning meetings and facilitate connections with strategic partners and resources as applicable;
  • Monitor the progress of ongoing studies including enrollment and subject visit tracking in OnCore;
  • Serve as an expert resource to PIs, study coordinators and other research staff with regard to study-specific protocol requirements and problem solving related to clinical, logistical, financial and regulatory issues;Assist PIs, study coordinators and research staff in the development of subject recruitment strategies, identification of barriers to enrollment, and implementation of appropriate interventions.

In concert with the Medical Directors and the Associate Director of Operations, ensure up-to-date standard operating procedures (SOP), templates, provisions, etc., that staff are knowledgeable regarding SOPs, and that all activities are conducted in accordance with SOPs. Serve as a 'super user' for the CTMS and MiCHART for research purposes. Keep abreast of upgrades and work with research office staff to implement process changes reflecting those changes. Manage mail groups for the dissemination of information. Other duties and responsibilities as assigned.

Required Qualifications*

Master’s Degree or equivalent preferred. Mastery of previous positions required. Ability to work independently or in a team environment. 5 or more years’ clinical research experience at a progressively involved level. Clinical coordination or related clinical research experience required. Solid understanding of the study team role in opening and managing clinical trials. Positive attitude and strong customer service focus.

Desired Qualifications*

ACRP or SoCRA Certification desired.

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.

 

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.  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.