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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 Clinical Research Associate in the Oncology Clinical Trial Support Unit (O-CTSU) providing clinical site monitoring, site management and regulatory oversight support of local and multi-site investigator-initiated trials 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).

The incumbent will act as a liaison between the clinical sites, coordinating center study staff, the O-CTSU as well as Sponsors/Supporters to ensure that clinical trials are conducted in compliance with the protocol, and applicable institutional and regulatory requirements. The successful candidate will facilitate and manage discrepancies within the study databases (including CTMS and electronic case report forms/data capture systems) and perform source document review/source document verification.

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-Associate position on the Michigan Medicine CRC Career Ladder is required, including experience with various committees at the University. This position gives back to the institution through mentoring others on study management and participating in training and development of junior clinical research professionals. This position demonstrates advanced skills and knowledge along with the ability to support, guide, train, and mentor study team members in the implementation of study related activities. This position applies critical thinking and creative problem-solving skills across a wide variety of clinical studies. This level of CRC develops new processes, procedures, tools, and training to enhance clinical research activities across the competency domains. 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, guide, mentor, and support.

Responsibilities*

Characteristic Duties and Responsibilities:

Expert level 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 Site Monitoring. Examples of duties a successful candidate in this role will perform:

• Conduct remote and onsite monitoring visits per study requirements.
• Coordinate and facilitate accurate timing of monitoring visits (inclusive of preparation/follow-up activities).
• Generate written communication to participating site staff including monitoring visit scheduling, findings, and required actions.
• The incumbent will be working on simple to moderate projects.
• Create written reports reflecting monitoring activities, findings, and actions for filing in the trial master file and sharing with Sponsors and/or Supporters, as required.
• Participates in project teams to develop and employ methods to manage non-compliance (as applicable). Follows up with respective staff for significant and/or unexpected findings and escalate (as applicable).
• Collaborates with study staff to ensure effective/efficient sharing of information.
• Create regulated documents for accurate tracking, collection, and recording of review/outcomes.
• Support maintenance of master trial files and manages the study progress in relation to the project timelines.
• Follows through with O-CTSU and clinical site staff questions/concerns/issues.
• Monitor adverse events for seriousness and facilitate the AE/SAE reporting process to ensure that all adverse events are reported to the O-CTSU. Expeditiously route AE and SAE information between staff, PI, and oversight agencies as appropriate.
• Assist study teams with aspects of clinical trial coordination including: conduct Site Selection Visits (as applicable), Site Initiation Visits, Interim Site Visit and Close-out Visits per study, institutional and applicable regulatory/contractual requirements.
• Serves as a resource and contact person for active protocols.
• Act as a liaison between the clinical site(s) and the O-CTSU to resolve any CTMS and/or eCRF issues/queries/DCFs that may arise throughout the course of the study, as required.
• Liaison between clinical team and research team to develop processes, troubleshoot complications and facilitate communication.
• Successfully integrate the workflow of many studies running simultaneously.
• Maintain current PEERRS, or OHRP certification; knowledge and application of the Code of Federal Regulations (CFR), Good Clinical Practice (GCP), and FDA regulations.
• Assist in training other staff.
• Staff members are expected to work well in a team setting, but also independently when appropriate and regularly exercise good judgment in setting priorities, resolving operational problems, and applying policies, procedures, and method, while maintaining the strictest of confidentiality at all times.
• Travel may be required for instances where remote monitoring may not be permittable (up to 20%).

This position reports directly to a unit Administrator.

Could provide Functional supervision (likely in limited capacity such as training) of 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 01/01/2024. After 01/01/2024 certification is required within six months of date of hire
• Minimum of 3+ years direct related experience 
  • Experience must meet minimal equivalent experience at each level within the Michigan Medicine CRC Career Ladder
• 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 the 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*

• 6+ years of direct related experience
• Experience coordinating multi center investigator-initiated trials

Work Locations

Monday through Friday, core business hours

Additional Information

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.