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. This position should begin to serve on various clinical research committees at the University level. This position demonstrates advanced skills and knowledge along with the ability to support, guide, train, and demonstrate the implementation of study related activities. This position applies critical thinking and creative problem-solving skills across a wide variety of clinical studies. This position contributes to the development of new processes, procedures, and tools to enhance clinical research activities across the competency domains and conducts quality assurance/quality control checks on their work. This level of CRC 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, demonstrate, develop, guide, and support.

Job Specific Description:

The Division of Urologic Oncology within the Department of Urology is currently seeking a highly motivated individual to work as a local and statewide study coordinator for three separate but related prostate cancer studies and may require travel to Michigan Medicine satellite clinics. These studies relate to prostate cancer detection and identification of aggressive forms of prostate cancer, and all relate to use of molecular diagnostic platforms for eligible patients. Candidates will be expected to perform independently as well as part of a team and will be absolutely integral to the successfully completion of these studies. Basic wet bench work may be required for processing of blood and/or urine samples. This candidate should possess strong leadership abilities to guide a team while working closely under the supervision of the principal investigator

• Explains the variety of communication channels, roles and relationships and outlets for study results that impact the conduct of clinical research.
• Applies good communication and teamwork practices as well as effective presentation and communication of study results.
• Function as liaison between study participant, investigator, sponsor, and other stakeholders.
• Demonstrates understanding of protocol elements/requirements and demonstrate the ability to execute study procedures.
• Demonstrates the ability to anticipate and mitigate the potential for protocol noncompliance.
• Describes protocol structure and explains how to interpret study requirements to ensure study compliance.
• Demonstrates accurate implementation of protocol procedures.
• May assist with creating posters, abstracts, articles, and study protocol drafting and design.
• Explains and performs study non?GCP related study management activities.
• Performs study procedures with minimal supervision.
• Triages simple subject concerns and issues appropriately.
• Schedules, assists with preparation for, and attends study initiation meetings, monitor visits, and audits.
• Ensures integrity of specimen management (collection, processing, packing/shipping, storing, labeling, tracking, etc.).
• Comfortable with basic clinical lab equipment such as a centrifuge, various freezers, pipettes, and standard laboratory safety requirements and guidelines.
• Explains the role of the Clinical Trial Support Unit (CTSU) for initiating new studies, and for subject visit billing.
• Participates in regular study meetings and drafting the meeting agenda to distribute. 
• Properly completes payment forms and pays
• participants accordingly.
• Demonstrates the ability to document data in accordance with ALCOA?C principles.
• Explains how to utilize information from the EMR and study databases.
• Completes complex data collection during study visits.
• Demonstrates ability to resolve
• data queries.
• Explains and performs study operational activities in compliance with Good Clinical Practice (GCP)
• Explains proper documentation techniques as outlined in the ICH?GCP guidelines.
• Explains the difference between Adverse Events (AEs), Serious Adverse Events (SAEs), and Other Reportable Information and Occurrences (ORIOs), can appropriately identify them and report them.
• Works with the Office of Research Compliance Review to create and post studies in ClinicalTrials.gov and obtain the NCT.
• Demonstrates understanding of University and Federal guidelines in order to assist with Investigator Initiated studies.
• Collaborates with MIAP for INDs and IDEs.
• Demonstrates an understanding of the elements of subject safety, related documentation, and reporting. Recognizes situations requiring prompt escalation and demonstrates actions to minimize risks.
• Demonstrates proficiency in all eResearch applications and submissions, such as continuing renewals and amendments.
• Demonstrates ability to maintain essential regulatory documents as outlined in the ICH?GCP guidelines.
• Maintenance of updated regulatory documentation.
• Managing timesheet approvals and overseeing team operations

Supervision Received:

This position reports directly to the Principal Investigator.

Supervision Exercised:

Will provide functional supervision of staff for the team under the principal investigator, to include but not limited to timesheet approvals and requests, training and onboarding new staff, and assisting with team meetings.

• 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.  Candidates must be eligible to register or take the exam at date of hire and the certification must be completed or passed etc. within six months of date of hire.  (Please review eligibility criteria from SoCRA or ACRP prior to applying.)
• Minimum 3 years of directly related experience in clinical research and clinical trials is necessary.  (Please review SoCRA's Definition of a Clinical Research Professional for qualifying experience prior to applying.)  

• 6+ years of direct related experience

Training Requirements: 

All training requirements of previous level.

• PEERRS, HIPAA, CITI GCP
• eRPM Regulatory training
• Attends and participates in all training assigned to this level.
• Professional certification through ACRP (CCRC) or SoCRA (CCRP); external hires require earning certification within 6-month probationary period
  • SOCRA Eligibility requirements can be found at this link: https://www.socra.org/certification/ccrp-certification-exam/candidate-eligibility/
  • ACRP Eligibility requirements can be found at this link: https://acrpnet.org/certifications/crc-certification/
• Any additional training that may be required by a sponsor

The work schedule is Monday-Friday with 8-hour work days. Flexibility with schedule start and end times may be needed to accommodate clinic needs. No weekends.

Positions that are eligible for hybrid or mobile/remote work mode are at the discretion of the hiring department. Work agreements are reviewed annually at a minimum and are subject to change at any time, and for any reason, throughout the course of employment. Learn more about the work modes.

This is a term-limited appointment (2 years) with the possibility of extending based off funding. 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.

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.

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.

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.

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