Job Information
University of Michigan Clinical Research Coord Inter TERM-LIMITED in Ann Arbor, Michigan
Clinical Research Coord Inter TERM-LIMITED
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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
We are seeking a responsible, motivated, individual who will independently provide study coordination for simple and moderately complex clinical research studies. As a member of a coordination team, this clinical research coordinator (CRC) position may help support a portfolio of projects with varying levels of complexity. Coordinator experience and mastery of all job duties from the CRC-Associate position on theMichigan Medicine CRC Career Ladder (https://medresearch.umich.edu/office-research/about-office-research/our-units/clinical-trials-support-office/study-coordinator-support/clinical-research-coordinator-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. This position has a term limitation of 2 years, with an option to extend if funds are available.
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*
Characteristic Duties and 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
Responsibilities:
Manages and coordinates all aspects of assigned clinical research portfolio including but not limited to:
Regulatory submissions, creation/maintenance of regulatory binders
Subject screening, consenting, enrollment, management of study records
Data collection, entry, sharing, storage, management, query resolution
Create and complete case report forms, source documentation, study documents and tools
Database/survey development in various electronic platforms (REDCap, Qualtrics)
Effectively communicate with sponsors; coordinate, prepare, and attend visits for site initiation, monitoring, auditing, and/or closeout
Assess studies for execution and troubleshoot potential implementation issues.
Provide cross-coverage on projects
Performs study procedures with accuracy
Demonstrates ability to triage complex study concerns appropriately
Demonstrates ability to manage increasing levels of protocol complexity and/or volume efficiently
Contributes to the development of processes and tools to capture data in accordance with ALCOA-C principles
Resolves complicated queries
Demonstrates an understanding of Investigational products development process and applies key regulatory requirements to control these processes
Monitors site compliance with subject safety reporting, escalates issues, and contributes to the development of tools and processes to enhance subject safety during the conduct of a clinical study
Provides logistic and regulation guidance on Investigator Initiated Studies for adherence to University and Federal guidelines
Provide other administrative support for study activity including management of subject reimbursement and payments
Participates in trainings specifically for maintaining certification as a Clinical Research Professional
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.)
Excellent organizational skills and attention to detail.
Superb interpersonal skills ? comfortable speaking with healthcare providers, research sponsors, and patients.
Ability to communicate effectively and professionally in both verbal and written form.
Ability to work independently but also within a team.
Ability to prioritize multiple tasks and meet deadlines are a must.
Desired Qualifications*
6+ years of direct related experience
Excellent communication skills
Ability to foresee needs of investigators/study teams and respond accordingly
Possess critical thinking skills
Ability to triage complex study concerns appropriately
Work Schedule
This is a full-time regular position. Monday-Friday: 8am-4:30pm; On-site work required. Travel to satellite clinics may be required.
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) .
Additional Information
This is a term-limited appointment for 2 years, with an option to extend if funds are available. 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.
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
260075
Working Title
Clinical Research Coord Inter TERM-LIMITED
Job Title
Clinical Research Coord Inter
Work Location
Ann Arbor Campus
Ann Arbor, MI
Modes of Work
Onsite
Full/Part Time
Full-Time
Regular/Temporary
Regular
FLSA Status
Exempt
Organizational Group
Medical School
Department
MM Orthopaedic Surgery
Posting Begin/End Date
2/19/2025 - 3/12/2025
Career Interest
Research
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