Clinical Research Coordinator
The Department of Orthopedics Clinical Research Coordinator will support clinical research activities for the department, division, and/or center. This position will serve as a vital resource for investigators to partner and facilitate the conduct of various research studies and liaison with research administration as well as various institutional committees. The incumbent will serve as a point of contact for assigned areas and provide day to day support to the ongoing studies, publications, presentations, posters, and other academic work as assigned. As a result, the clinical research coordinator will help to advance research throughout the department and divisions as assigned. This position will also support projects and assumes responsibility for the day-to-day operation of program activities, including the regulatory functions, project management, administrative tasks, study conduct, chart review, study enrollment, basic data analysis, RedCap, interpretation of results and reporting of research studies and experiments. Possesses advanced knowledge of research practices.
Primary Responsibilities:
- Follows all aspects of Standard Operating Procedures and Good Clinical Practices in the conduct of clinical research; collects and prepares documents as required by sponsoring agencies; attends Investigator Meetings, as assigned;
- Develops source documents, parental permission and assent documents for submission to IRB. Coordinates IRB submissions for assigned studies, maintains regulatory documents during conduct of study; develops and utilizes study participant and family teaching tools for study purposes; interfaces with representatives of sponsoring agencies.
- Participates in the conduct of parental permission/assent process for assigned studies; schedules study visits with study participants in accordance with study protocols; develops strategies to assure compliance of study participants with protocol requirements.
- Performs clinical data gathering and measurements and monitoring of data integrity, including data completeness, accuracy and quality. Maintains study databases
- Participates in training nursing and ancillary study staff for study purposes; recruits, screens and enrolls sufficient number of study participants in conformance with protocol requirements.
- Assists in identifying, reporting and following-up on Serious Adverse Events.
- Assists in the maintenance of study medication accountability records; prepares clinical specimens for shipment to central laboratories.
- Coordinates monitoring activities with Sponsor’s representative(s). Completes Case Report Forms; responds to sponsor queries, prepares for audits by sponsor, IRB and/or the FDA/DHHS
Qualifications:
- Bachelor’s degree in medical or science related field required
- 1-3yrs Experience with facilitating research projects and regulatory functions, Clinical Research Certification (CCRP, CCRC) preferred
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