As an integral member of the research team, the Clinical Subjects Coordinator (CSC) will help ensure that clinical research studies at the University of Michigan Kellogg Clinical Research Center (KCRC) are executed in the highest quality and compliant manner. In order to succeed, the applicant must possess exceptional organizational skills, uncompromising integrity, a love of people, and a strong willingness to learn new skills.
COMMUNICATIONS: The CSC is expected to assist research coordinators in facilitating 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 may 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, perimetry, maze testing, etc.). In addition, the CSC may help the research coordinator input data into case report forms (CRFs), maintain studies in the OnCore clinical trial management system, and resolve 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 CSC is expected to actively support an environment of strict regulatory compliance.
RECRUITMENT: The CSC may 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 CSC is expected to possess a willingness and capacity to learn protocol specific testing requirements.
OTHER: Clinical research regulations and best practices are constantly changing. The CSC is expected to remain current with these changes as they occur. In addition, the CSC will need to become proficient with phlebotomy.
Committed to prioritizing the welfare of the research volunteer Exceptional organizational skills Uncompromising integrity Capacity and willingness 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)
This is a 3-year term limted position pending fund with no RIF rights.
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.
The Kellogg Eye Center seeks to improve lives through curing, preventing and treating eye disease.
Guiding Principles: Teamwork, Caring, Innovation, and Integrity
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.
The University of Michigan is an equal opportunity/affirmative action employer.
Internal Number: 172427
About University of Michigan - Ann Arbor
A great university is made so by its faculty and staff, and Michigan is recognized as one of the best universities to work for in the country. The Michigan culture is known for engaging faculty and staff in all facets of the university to create a workplace that is vibrant and stimulating.For two consecutive years, the Chronicle of Higher Education has placed U-M in its "Great Colleges to Work For" survey. In particular, the university earns high marks for strong relations between faculty and administrators, a collaborative system of governance, strong pay and benefits, and a healthy work/life balance.