Job Information
University of Michigan Clinical Research Coordinator I / Assistant Clinical Research Coordinator in Ann Arbor, Michigan
Clinical Research Coordinator I / Assistant Clinical Research Coordinator
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How to Apply
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.
Job Summary
This position may independently provide study coordination for simple and moderately complex clinical research studies. As a member of a coordination team, this position may help support a portfolio of projects with varying levels of complexity. Mastery of all job duties from the CRC-Assistant position on theMichigan Medicine CRC Career Ladder (https://research.medicine.umich.edu/our-units/clinical-trials-support-office/clinical-research-coordinator-career-ladder) is required for the CRC-Technician position.
Mission Statement
Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally. Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society.
Responsibilities*
Experience as part of a team with 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
Assist study team with aspects of clinical research coordination including: identifying potential subjects, screening subjects, consenting and enrolling subjects, and collecting and managing patient and laboratory data for clinical research subjects.
Collect specimens and monitor study subjects. Assist in monitoring of test results. Ensure integrity of specimens (collection, processing, shipping/packing, storing, labeling, tracking, etc.).
Perform data management and results reporting, such as entering information into Case Report Forms (CRFs). Assist with collection of external medical records for study reporting purposes. Ability to identify and report Adverse Events (AEs) and Serious Adverse Events (SAEs).
Prepare IRB submissions including the initial applications, as well as amendments and scheduled continuing reviews, progress reports, safety reports, and adverse event reports.
In coordination with other M-CTSU staff, communicate with sponsors concerning progress of clinical trials, billing calendar/budget issues, subject related problems, recruitment strategies, and specific policies and procedures.
Act as liaison between study team and sponsors, IRB, federal, state, and university officials and other regulatory agencies to maintain accurate communication of costs, policy changes, fiscal requirements, and other regulatory issues. Serve as key resource to research participants and collaborators. Provide support for audits and monitor visits.
Work collaboratively with the M-CTSU team by maintaining a good rapport and communication with research teams and faculty, as well as patients and families.
Prepare and organize space for study related materials and equipment.
The person in this position will frequently traverse around the medical campus and will occasionally spend long hours (full days) on their feet. There is a need to move, transport, and position clinical research supplies weighing up to 50 pounds across the hospital campus.
Staff members are expected to work independently and regularly exercise good judgment in setting priorities, resolving operational problems, and applying policies, procedures, and methods, while always maintaining the strictest of confidentiality.
This person may help mentor and train other CRC staff through formal and informal presentations.
Other administrative responsibilities as assigned.
Supervision Received:
This position receives direct supervision and reports directly to the unit Administrator, CRC-Lead, or CRC-Project Manager.
Supervision Exercised:
None.
Required Qualifications*
Clinical Research Technician
Associate's Degree or equivalent in combined education and clinical research experience
Minimum of 1+ years direct related experience OR advanced degree in health-related areas OR 3 years of related human subjects experience
Clinical Research Assistant
- High School Diploma or GED
Desired Qualifications*
Bachelor's Degree in Health Science or an equivalent combination of related education and experience is desirable
An understanding of medical terminology preferred
Knowledge of Michigan Medicine policies and practice
Familiarity with OnCore, Epic, MiCHART, and eResearch applications
PEERS, CITI, or NIH Protection of Human Subjects Training Certification
Experience with local and central IRB application processes
Motivated to help others
Work Schedule
This position will primarily support work M-F during normal business hours.
Work Locations
Ann Arbor
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 thework modes (https://hr.umich.edu/working-u-m/my-employment/ways-we-work-resource-center/ways-we-work-implementation-group/modes-work) .
Underfill Statement
This position may be underfilled at the CRC-Assistant title based on selected candidates’ qualifications.
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 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.
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.
Job Detail
Job Opening ID
253778
Working Title
Clinical Research Coordinator I / Assistant Clinical Research Coordinator
Job Title
Clinical Research Technician
Work Location
Ann Arbor Campus
Ann Arbor, MI
Modes of Work
Mobile/Remote
Full/Part Time
Full-Time
Regular/Temporary
Regular
FLSA Status
Nonexempt
Organizational Group
Medical School
Department
MM Research-Clin Trial Units
Posting Begin/End Date
11/04/2024 - 12/02/2024
Career Interest
Research
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