Clinical Research Coordinator
Clinical Research Coordinator
The Clinical Research Coordinator will develop, implement, and coordinate research and administrative procedures for the successful management of clinical trials. The CRC will perform diverse administrative duties requiring analysis, sound judgment, and a high level of knowledge of study specific protocols. The incumbent reports to Charbel Moussa, MBBS, PhD, Associate Professor of Neurology, Director, TNP, Department of Neurology. Duties include but are not limited to:
- Work with patient navigator/outreach coordinators and clinical research unit (CRU) and schedule visits for all patients who are enrolled in clinical trials in the Translational Neurotherapeutics Program (TNP).
- Coordinate with clinicians, including nurses and physicians to perform all procedures as outlined in the clinical protocol.
- Maintain compliance with billing, regulatory agencies, federal government (NIH and FDA), sponsors (industry and government), institutional (IRB, clinical trials office and other advisory boards), and international regulatory agencies.
- Coordinate and update all members of the data safety monitoring board (DMSB) on study progress and schedule meetings as required.
- Schedule and assist monitor's visits internally and externally to ensure progress and integrity of all studies.
- Maintain all records as required by the university, federal and other regulatory agencies and sponsors.
- Ensure that all databases within and outside the university are completed and up to date and maintain heads up on all billing and financial matters, including invoicing.
- Coordinate with study team and departments including labs, pharmacy, imaging, tissue collection and storage.
- Ensure a cordial, collegial and professional relationship with study team and partners of Georgetown University.
- BS/BA in Life Science or related discipline.
- Requires a minimum 3 years' experience coordinating clinical research studies (including Industry-sponsored and investigator initiated research studies)
- Strong interpersonal skills with attention to detail is a must. Demonstrated ability in positive relationship building, with strong verbal and written skills required
- Demonstrated proficiency with word processing, spreadsheet, database, and presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, SharePoint) and with clinical trial master filing systems
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