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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.

Summary

This position can function in a remote office capacity (geographical location anywhere in the contiguous United States is acceptable).

This position will serve as a Project Manager in the Oncology Clinical Trial Support Unit (O-CTSU) providing project management, regulatory and data management oversight and clinical monitoring support to faculty and research teams for the University of Michigan Rogel Cancer Center - an NCI-Designated Comprehensive Cancer Center and a member of the National Comprehensive Cancer Network (NCCN).

We are among the top-ranked national programs in research and patient care with members holding $120M in annual direct research funding. Our mission is to reduce the cancer burden and improve cancer outcomes through research, innovation, and transdisciplinary collaboration. With the Oncology CTSU, you will join a diverse team of 150 clinical research professionals dedicated in moving this mission forward through cutting-edge early phase trials to practice-changing phase III. As a team member, we will invest in your education, training, career development and certification. We also offer a variety of specialized roles and growth opportunities to fit your desired career path and goals. People want MichiganAnswers™. Help discover them.

This position has the opportunity to function in a fully remote capacity.

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.

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*

Characteristic Duties and Responsibilities:

Independent knowledge, skills, and abilities within all 8 competency domains is expected:

1. Scientific Concepts and Research Design
2. Ethical Participant Safety Considerations
3. Investigational Products Development and Regulation
4. Clinical Study Operations (GCPs)
5. Study and Site Management
6. Data Management and Informatics
7. Leadership and Professionalism
8. Communication and Teamwork

Due to the complex nature of multi-site Oncology Clinical Trials, a team comprised of clinical research coordinators specializing in Project Management, Site Monitoring, Central Monitoring, and Regulatory work together to cover all aspects of the clinical research coordinator role. The clinical research coordinator hired for this posting will specialize in Project Management. Examples of duties a successful candidate in this role will perform:

This position will provide project management, regulatory and data management oversight and clinical monitoring support for multi-site trials coordinated by the Oncology Clinical Trials Support Unit (CTSU) from trial start-up through trial closeout.

• The incumbent will act as a liaison between the clinical sites, the CTSU and sponsors/agencies/cooperative groups to ensure that clinical trials are conducted in compliance with the protocol, and applicable institutional and regulatory guidelines.
• The incumbent will be handling moderate to complex projects.
• Develop and maintain study manual of operations, standard data collection procedures, Monitoring Plans, and other study documents.
• Maintain master trial files and manage the study progress in relation to the project timelines.
• Assure that the clinical sites are enrolling subjects, collecting data, and conducting the trial in compliance with approved protocol version, GCP, and ICH guidelines and verify patient eligibility.
• Prepare clinical sites for study start-up by reviewing and tracking regulatory documents, ordering start-up supplies, and conducting site initiation visits.
• Conduct ongoing site monitoring visits. Monitor adverse events for seriousness and facilitate the AE/SAE reporting process to ensure that all adverse events are reported to the study supporter and all participating site IRBs.
• Oversee the maintenance and organization of project documentation and records. Act as a liaison between the clinical site(s) and the data coordinating center to resolve any issues that may arise throughout the course of the study.
• Other responsibilities may include but are not limited to:
  • Run regular study meetings.
  • Train and support study team members on a range of communication and teamwork best practices. Mentor other staff members.
  • Demonstrate professionalism and apply basic leadership practices in all aspects of the role.
  • Perform complex study procedures with accuracy.
  • Develop tools, processes, and training to enhance the administration and execution of clinical trials.
  • Participate in group and department initiatives. Perform other duties as assigned by management.

This position reports directly to a unit Administrator.

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

Required Qualifications*

• Bachelor's Degree in Health Science or equivalent in combined education and clinical research experience
• Professional certification through ACRP (CCRC) or SOCRA (CCRP) must be achieved by 01/01/24.  After 01/01/24, certification is required within six months of date of hire.
• Minimum of 5+ years direct related experience
  • Experience must meet minimal equivalent experience at each level within the Michigan Medicine CRC Career Ladder
  • Includes 2+ years as a CRC-Intermediate or above
    • Or external equivalent level
  • Includes minimum of 2+ years of experience in the coordination of multi-site studies 
• Strong background and/or experience in clinical research site management, regulatory management, and data management
• Excellent written and verbal communication skills
• Strong organizational skills with ability to multitask and prioritize
• Must have exceptional attention to detail and understanding of compliance issues with regard to human subject research
• Outstanding teamwork and customer service orientation
• Ideal candidate will have strong knowledge of 45 CFR part 46 and 21 CFR parts 50

Desired Qualifications*

• Master's Degree in Health Science Field
• 9+ years of direct related experience
• Experience coordinating multi center investigator-initiated trials

Work Schedule

Monday through Friday, core business hours

Underfill Statement

This position may be underfilled at the CRC-Senior title based on selected candidates' qualifications and the review and approval of the Michigan Medicine CRC Governance Board.

Additional Information

The use of this title requires approval by the University of Michigan Clinical Research Coordinator Governance Board to ensure equity in title placement across Michigan Medicine.

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 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 Michigan and the world.  We strive to create a work culture where each team member feels respected, valued, and safe.

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, including boosters when eligible, are required for all University of Michigan students, faculty and staff across all campuses, including Michigan Medicine.  This includes those working remotely.   More information on this new policy is available on the Campus Blueprint website or the UM-Dearborn and UM-Flint websites.