Clinical Research Coordinator
Clinical Research Coordinator, Clinical Research Unit (CRU) - Georgetown University Medical Center
Coordinate and participate in clinical research studies conducted by principal investigator(s) at Georgetown University Clinical Research Unit (CRU); coordinate and participate in a variety of complex activities involved in the collection, compilation, and documentation of clinical research data. Coordination of the study will include but will not be limited to study initiation tasks including all regulatory documentation and subject recruitment, study enrollment tasks, study conduct, and study closeout. Study conduct will include obtaining blood samples, cultures, tissues and other specimens for laboratory analysis, questionnaires, and data management as indicated and allowable under the state board practice act. The incumbent will participate in training to obtain certifications and ensure Good Clinical Practices are followed. Required to comply with institutional policies regarding data management and usage of OnCore Clinical Trial Management System (CTMS) as applicable.
The study coordinator is responsible for ensuring that all aspects of clinical trials implementation are conducted smoothly and in a safe manner. The subjects, PIs, sponsors, and the institution depend on the study coordinator for accurate and safe implementation of the clinical protocol. Errors in study conduct result in protocol deviations, which jeopardize the integrity of the clinical data, the reputation of the PI and institution and the safety of the subject. Duties include but are not limited to:
- Responsible for all tasks assigned by the PI/supervisor as they relate to study conduct.
- Responsible for all tasks assigned by the PI/supervisor for study enrollment.
- Responsible for all tasks assigned by the PI/supervisor as they relate to study closeout.
- Comply with all GUMC and Clinical Trial Management procedures as well as all Medicare compliance procedures.
- Comply with all GUMC training requirements as applicable to position (CITI, COI, ACRP/SOCRA or equivalent, Bloodborne Pathogens, Billing Compliance).
- Attend a minimum of 6 GUMC research meetings (CRN, CROO, LCC) per year.
- Complete and upload time & effort forms on-time each month into designated university Box folder.
Bachelor's Degree preferred or an Associate's degree with one to two years' experience; Consideration given to an equivalent of education and work experiences that demonstrate aptitude for research facilitation
Strong organizational skills
Excellent interpersonal, written and organizational communication skills
Detail oriented with excellent analytical skills
Demonstrated ability to maintain confidentiality
Experience in a healthcare setting preferred
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