Clinical Research Coord Assoc

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; NCT), 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 (My Prostate Score  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 depending on complexity that range from moderate to complex. Coordinator experience and mastery of all job duties from the CRC-Technician position on the Michigan Medicine CRC Career Ladder is required. This position should be able to perform tasks and make decisions independently, consistently, and accurately, and demonstrate that they have achieved a moderate level of expertise in all their skills and abilities resulting in high quality work.

It is expected that the individual in this position is able to apply their skills to a broad range of different types of clinical studies, navigate available resources appropriately, effectively use all tools and job aids at their disposal and operate electronic medical systems with proficiency. This position can perform the majority of tasks independently and perform quality checks of their work.

They also know where and how to identify appropriate resources and support and are able to discern when to escalate issues needing additional intervention.

Responsibilities
* Characteristic

Duties and Responsibilities:

Independent 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…