As an integral member of the research team, the Clinical Research Coordinator (CRC) will help ensure that clinical research studies are initiated and 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. We are seeking a candidate who can act as a study coordinator for the eHealth laboratory at the Kellogg Eye Center on a federally funded research grant.
RECRUITMENT: The CRC will work with the investigator(s) in order to recruit and retain study participants. The ideal candidate will be able to provide exceptional patient service. The CRC will be responsible for recruiting patients with corneal eye diseases for a longitudinal study (lasting 90 days for each participant), coordinating follow-up care for patients in the study and communicate study findings (as needed) with the patient’s health care team, managing data in a RedCap database, and generating progress reports on participant recruitment and study compliance. The study involves two locations, Michigan and Aravind Eye Care Systems in India. The CRC will be asked to coordinate quality of data from the Aravind site under the guidance of the PI.
COMMUNICATIONS: The CRC is be 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, administering surveys, inputting data into case report forms (CRFs), maintaining studies in the OnCore clinical trial management system, and resolving queries. The CRC will obtain study data from physicians for recording the clinical examination and information about the participant.
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 candidate will receive training from the Kellogg Eye Center and will work to ensure that the study remains in compliance.
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. The ideal candidate will have experience in ophthalmic health care or have a strong desire and comfortability with learning about eye health and disease.
OTHER: Clinical research regulations and best practices are constantly changing. The CRC is expected to incorporate these changes as they occur. The CRC will be expected to help manage work-study and research students (primarily from the School of Public Health and Medical School) who will support the project. There is the opportunity to travel to India (Aravind Eye Care Systems) as part of the role and responsibilities to coordinate efforts between the sites. If the candidate agrees to this travel prior to accepting the position, it would then be considered a job responsibility to travel to Aravind at least one time per year. If there is interest and skill, there may be opportunities to collaborate on publications, grant writing, and project management.
Prioritize multiple tasks, manage data accurately, meet deadlines and adhere to strict confidentiality requirements. Be organized, reliable, and detail oriented. Demonstrate professionalism, flexibility and empathy. 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
Possess a bachelor’s degree, preferably in public health or a related health field. Experience with Human Subjects research including previous study coordinator roles. Experience with patient recruitment and associated management of financial incentives. Experience with RedCap database management and generating reports. Knowledge of HIPAA and IRB rules and regulations. Experience as an ophthalmic technician (at least 2 years, at least COA or equivalent) or comfort learning to administer non-invasive basic eye health tests. 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 EPIC electronic health record (EHR) system Experience with the OnCore clinical trial management system (CTMS)
This is a three-year, term-limited position, with the possibility of extending to other projects with the research team(s) or participate on other grant funded projects in the future. At the end of the stated term, the appointment will terminate and will not be eligible for Reduction in Force (RIF) benefits.
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