As an integral member of a research team, the Clinical Research Coordinator (CRC) will help ensure that clinical research studies at the University of Michigan Kellogg Clinical Research Center (KCRC) are initiated and executed in the highest quality and compliant manner. In order to succeed, the applicant must possess exceptional organizational skills, uncompromising integrity, and a strong willingness to learn new skills.
COMMUNICATIONS: The CRC is expected to facilitate communications between sponsors and contract research organizations, research volunteers, investigators, regulatory personnel, and other key contributors such as the Clinical Trial Support Unit. The communications will include but are not limited to scheduling appointments, interfacing with the regulatory and financial authorities, working closely with study monitors, and problem solving.
DATA: The CRC will help carry out data acquisition through various testing modalities (e.g. visual acuity, refractions, intraocular pressure, etc.), inputting data into case report forms (CRFs), maintaining studies in the OnCore clinical trial management system, and resolving queries.
REGULATORY COMPLIANCE: Employees of the KCRC follow all local, state, and federal regulations regarding clinical research in addition to Good Clinical Practice and protocol specific guidelines. The CRC is expected to actively support an environment of strict regulatory compliance.
RECRUITMENT: The CRC will work with the investigators in order to recruit and retain study participants.
PROTOCOL SPECIFIC NEEDS: In addition to the broad technical skills needed in nearly every ophthalmic clinical study (e.g. visual acuity, refraction, intraocular pressure, etc.), each study often has unique needs. The CRC is expected to possess a willingness to learn protocol specific testing requirements.
OTHER: Clinical research regulations and best practices are constantly changing. The CRC is expected to incorporate these changes as they occur. In addition, the CRC will need to become proficient with phlebotomy.
- Committed to prioritizing the welfare of the research volunteer
- Exceptional organizational skills
- Uncompromising integrity
- Capacity to learn new skills as the positional needs change
- Ability to work both independently and as part of a team
- Experience with MS Word, Excel, Power Point, Outlook or equivalent
- Experience as an ophthalmic technician (at least 2 years, at least COA or equivalent). or willingness to participate in a formal training program
- Knowledge of general clinical research operations and regulations or a capacity to learn quickly
- Willingness to achieve professional certification such as SOCRA or equivalent
- Experience with the MiChart (Epic) electronic health record (EHR) system
- Experience with the OnCore clinical trial management system (CTMS)
- Computer keyboard proficiency
- At least a bachelor's degree (or equivalent)
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Job openings are posted for a minimum of seven calendar days. This job may be removed from posting boards and filled anytime after the minimum posting period has ended.
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The University of Michigan is an equal opportunity/affirmative action employer.