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.

Summary

This clinical research coordinator (CRC) position may provide study coordination for multiple clinical research studies of any complexity. Coordinator experience and mastery of all job duties from the CRC-Intermediate and/or CRC-Senior position on the Michigan Medicine CRC Career Ladder is required. This position demonstrates the ability to lead study team members in the implementation of study related activities. This position develops new processes, procedures, tools, and training to enhance clinical research activities across the competency domains and conducts quality assurance/quality control checks on the work of others. This position continues to build on their competency foundation by making greater investments in their ongoing continuing education and professional development. Key behavioral competency descriptors include: Design, develop, evaluate, lead, guide, mentor, and support.

The Department of Internal Medicine, Division of Hematology/Oncology is currently seeking a full-time Clinical Research Coordinator - Lead to manage the PROMISE Consortium, retrospective database studies and a prospective multi-site kidney cancer project, Odyssey (Outcome Database to prospectivelY aSSess the changing therapY landscape in Renal Cell Carcinoma).

The Prostate Cancer Precision Medicine Multi-Institutional Collaborative Effort (PROMISE), formed in early 2020, is a consortium of 18 academic institutions working together to create a powerful clinical-genomic platform to interrogate and address data gaps that have arisen with increased genomic testing in the clinical management of prostate cancer.

PROMISE Consortium | Internal Medicine | Michigan Medicine | University of Michigan (umich.edu)

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 Work at Michigan?

Being part of something greater, of serving a larger mission of discovery and care — that's the heart of what drives people to work at Michigan. In some way, great or small, every person here helps to advance this world-class institution. It's adding a purpose to your profession. Work at Michigan and become a victor for the greater good.

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*

Daily Regulatory/Data Management tasks:

• Assists project team as needed during periods of transition, training of mentors and high volume workload
• Serves as a resource for the project team, providing guidance regarding IRB, ICH, GCP, IRB and HIPAA regulations
• Drafts responses to sponsors, programs and external agencies when needed to support project team or inform/enforce UMHS/Cancer Center policy
• Provides feedback on design/creation of study specific documents and assists in training personnel to develop them

Project Management tasks:

• Oversees audit preparations and works with auditors as team lead.
• Problem solves with clinical and project teams to address high level process issues that arise and affect the conduct of clinical research projects.
• Develops effort estimates for budgeting process for projects.
• Attends various programs meetings on an as needed basis in order to provide support to team and Consortium and reinforce roles, policies and procedures.
• Assists PI in troubleshooting various concerns and issues raised by internal and external collaborators.
• Assists PI with Consortium level study specific requests.
• Provides guidance to clinical research coordinators regarding policy and IRB regulations.
• Works with teams to develop processes and promote standardization within the project team and projects.
• Assists PI in monitoring budget adherence for clinical research projects and proactively identifying potential issues.
• Assists PI with identifying clinical research projects that are not meeting projected accrual targets, deadlines, etc. and brings them to the attention of the appropriate site leadership.
• Assists PI in providing Consortium accrual and progress reports.

Human Resources Related tasks:

• Provides leadership to project team members in the form of specific development plans tailored to each person’s professional development needs; suggests classes and reading etc. as appropriate.
• Empowered to provide coaching and mentoring, constructive feedback regarding performance, training techniques and problem solve personnel and interpersonal issues.
• Assists PI with distribution of workload; assesses capacity and workload of team Members.
• Assists PI with completion of annual review evaluations and mid-year reviews.
• Meets regularly with new hires to track training/orientation process and assesses progress.
• Assists PI with the development and implementation of performance plans as needed to address specific personnel issues.
• Assists PI in identifying staff who are promotion ready.

Management Assistance tasks:

• Reviews/assesses progress of project team in relation to ongoing workload.
• Assists PI in completing staff justification tools.
• Works with supervisor to review resumes and schedule interviews for open position.
• Handles items delegated up from team as appropriate.
• Participates in leadership initiatives as appropriate.

Required Qualifications*

• CRC Governance Committee review and approval
• Bachelor’s degree in Health Science or an equivalent combination of related education and experience is necessary.
• Certification is required through Association of Clinical Research Professionals (ACRP) as a Certified Clinical Research Coordinator (CCRC) or Society of Clinical Research Association (SOCRA) as a Certified Clinical Research Professionals (CCRP) or equivalent and must be achieved by 01/01/24. After 01/01/24, certification is required within six months of date of hire.
• Minimum 5 years of directly related experience in clinical research and clinical trials is necessary.

Desired Qualifications*

• Master’s Degree in Health Science or an equivalent combination of related education and related experience is desirable.
• 9+ years of direct related experience

Work Schedule

This is a full-time, 40 hour position.

This position will involve on site days at the Rogel Cancer Center (1500 E Medical Center Dr, Ann Arbor, MI 48109) and may be eligible for remote and/or flexible work opportunities at the discretion of the hiring department.

Additional Information

Provides Functional and/or Administrative supervision of one (1) or more staff in titles within the CRC Career Ladder.

Supervision Received: This position reports directly to Faculty Principal Investigator.

Supervision Exercised: CRC-Assistant

Michigan Medicine is firmly committed to advancing inclusion, diversity, equity, accessibility, and belonging, which are core to the culture and values of the Medical School Office of Research. Our community supports recruiting and cultivating a diverse workforce as a reflection of our commitment to serve the diverse people of Michigan and the world. We strive to create a work culture where each team member feels respected, valued, and safe.

This is a one year term-limited position, with the possibility of a 5-year term. Extensions will be based on available funding and performance. At the end of the stated term, your appointment will terminate, and will not be eligible for Reduction-in-Force (RIF) benefits. This term-limited appointment does not create a contract or guarantee of employment for any period of time as you will remain subject to disciplinary or other performance measures, up to and including termination, at the will of the University in accordance with existing University policy and standards for employee performance and conduct.

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.

Vaccine Requirements

COVID-19 vaccinations are required for all students, faculty and staff working in the following areas: Michigan Medicine including the Medical School, Dental School, University Health Service or the Mary A. Rackham Institute. This includes those working remotely and temporary workers. More information on this new policy is available on the U-M Health Response.

U-M EEO/AA Statement

The University of Michigan is an equal opportunity/affirmative action employer.