Clinical Research Coordinator, Clinical Research Services - Georgetown University Medical Center
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Georgetown University Medical Center (GUMC) is an internationally recognized academic medical center whose missions of research, teaching and patient care are carried out with a strong emphasis on community outreach. Clinical Research Services Shared Resources Center at GUMC are conducting multiple clinical research studies.
The Clinical Research Coordinator will coordinate and conduct clinical research studies within the CRS division but not limited to, grant funded research and/or industry sponsored clinical research conducted at Medstar Georgetown University Hospital. Mainly conducting research studies at Neurosurgery, Vascular Surgery and GI. The Clinical Research Coordinator will report directly to the manager of Central Research Support Services at Georgetown University.
The Clinical Research Coordinator position will be responsible for 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, data management and study closeout. Work interactions will be to:
ensure efficient participant flow, manage recruitment pipelines, oversee regulatory compliance, and ensure overall logistical progress on the project.
interface with faculty, collaborators, CRC pool and administrative staff to report project progress and troubleshoot barriers.
serve as point of contact for external and internal investigators looking to utilize Clinical Research Services.
work closely with affiliated departments and staff such as the CRC pool, CRU, CTTM, Neurology, Orthopedics, OSR, SAO, and CROO to ensure the integrity of each research protocol, adherence to study activities, regulatory compliance and other activities as required by the research protocols.
Functions described herein are performed in conjunction with Good Clinical Practice (GCP), and in accordance with all District of Columbia, federal laws, and Food & Drug Administration (FDA) regulations, as well as the institution's philosophy, policies and procedures.
Minimum of Bachelor's degree in a scientific or related field with a minimum of 1-3 years of clinical research experience.
In-depth knowledge of clinical research contracts and grants, clinical trials, protocols, FDA regulations, and complex visit structures.
Exceptional analytical skills to address complex and non-routine issues requiring the development of innovative solutions.
Excellent demonstrated interpersonal, verbal and written communication skills.
Ability to operate effectively in a changing organizational and technological environment.
Strong working knowledge of FDA, NCI, OHRP and/or ICH GCPs.
Ability to interpret and apply GUMC policies and federal, state, and local regulations.
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