Clinical Research Coord Inter

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Job Summary

The Division of Urologic Oncology within the Department of Urology is currently seeking a highly motivated individual to work as a study coordinator for genitourinary studies. Candidates will be expected to perform independently as well as part of a team and will be absolutely integral to the successful 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 and the independence to take ownership of assigned studies while working closely under the supervision of the principal investigator and laboratory manager.

A major focus of this position will be the UPRISE trial (Urine Prostate Screening Integrated with MRI for Early Detection of Prostate Cancer; NCT07526545), an NIH-funded randomized controlled trial conducted through the Michigan Prostate SPORE. UPRISE compares two pathways for detecting clinically significant prostate cancer in men with an elevated PSA and no prior biopsy: a urine biomarker test (MyProstateScore 2.0) first versus MRI first. The trial enrolls at multiple Michigan Medicine sites across the state and may expand beyond Michigan Medicine sites. The coordinator will support participant enrollment, urine specimen collection, and data collection across these sites.

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.

Responsibilities*

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

• Scientific Concepts and Research Design

• Ethical Participant Safety Considerations

• Investigational Products Development and Regulation

• Clinical Study Operations (GCPs)

• Study and Site Management

• Data Management and Informatics

• Leadership and Professionalism

• Communication and Teamwork

50% of Job Responsibilities

• Screens, recruits, and consents study participants and conducts study visits.

• Takes ownership of assigned studies, leading day-to-day study conduct and identifying and resolving problems independently.

• Functions as liaison between study participants, investigators, sponsors, participating sites across the state, and other stakeholders.

• Carries out study procedures accurately and in accordance with protocol requirements, with minimal supervision.

• Anticipates and mitigates the potential for protocol noncompliance.

• May assist with creating posters, abstracts, articles, and study protocol drafting and design.

• Performs non?GCP related study management activities.

• Triages subject concerns and issues appropriately.

• Schedules, assists with preparation for, and attends study initiation meetings, monitor visits, and audits.

• Works with the Clinical Trial Support Unit (CTSU) on initiating new studies and on subject visit billing.

• Participates in regular study meetings and drafts and distributes the meeting agenda.

35-40% of Job Responsibilities

• Utilizes information from the EMR and study databases.

• Completes complex data collection during study visits.

• Resolves data queries.

• Performs study operational activities in compliance with Good Clinical Practice (GCP).

• Follows proper documentation techniques as outlined in the ICH?GCP guidelines.

• Identifies and reports Adverse Events (AEs), Serious Adverse Events (SAEs), and Other Reportable Information and Occurrences (ORIOs).

• Applies University and Federal guidelines to assist with Investigator Initiated studies.

• Demonstrates an understanding of the elements of subject safety, related documentation, and reporting. Recognizes situations requiring prompt escalation and demonstrates actions to minimize risks.

• Prepares eResearch applications and submissions, such as continuing renewals and amendments.

• Maintains up-to-date essential regulatory documents as outlined in the ICH?GCP guidelines.

10-15% of Job Responsibilities

• Uses basic clinical lab equipment such as a centrifuge, various freezers, and pipettes, and follows standard laboratory safety requirements and guidelines.

• Ensures integrity of specimen management (collection, processing, packing/shipping, storing, labeling, tracking, etc.).

Required Qualifications*

• 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.)

Desired Qualifications*

• 6+ years of direct related experience

• Experience with oncology clinical trials, particularly genitourinary oncology

• Experience with OnCore, MiChart (Epic), REDCap, and eResearch

• Experience with biospecimen collection, processing, and shipping

• Experience coordinating multi-site studies

Modes of Work

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.

Additional Information

Supervision Received:

This position reports directly to PI and Project Manager, with Amy Kasputis as day-to-day manager.

Supervision Exercised:

None. This position has no direct reports but is expected to demonstrate leadership and independence in the day-to-day conduct of assigned studies.

Michigan Medicine (or unit specific name) 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.

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.

U-M EEO Statement

The University of Michigan is an Equal Opportunity Employer. We are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants, including protected veterans and individuals with disabilities.