Clinical Research Coordinator 2 - Georgetown University Medical Center

Located in a historic neighborhood in the nation's capital, Georgetown offers rigorous academic programs, a global perspective, exciting ways to take advantage of Washington, D.C., and a commitment to social justice. Our community is a tight knit group of remarkable individuals interested in intellectual inquiry and making a difference in the world.

Requirements

As a top academic health and science center in the United States, Georgetown University Medical Center seeks to provide, in a synergistic fashion, excellence in education — training physicians, nurses and other health care professionals, as well as biomedical scientists — and cutting-edge interdisciplinary research collaboration, enhancing our basic science and translational biomedical research capacity in order to improve human health. Emphasizing service, we are dedicated to the Catholic, Jesuit principle of cura personalis — “care of the whole person.” Our partnerships with organizations in the region strengthen our work and expand its reach. 

The Clinical Research Coordinator 2 (CRC2) is responsible for managing and coordinating the ALL ALS studies, primarily in the disease states of Neuromuscular Disorders (ALS). Coordination and management of such studies is both a dynamic and demanding responsibility that requires refined technical, organization, interpersonal, and coordination skills. The CRC2 is responsible for learning the schedule of assessments for each trial, and for coordinating each visit, which involves extensive preparatory work/pre-visit planning. Additional responsibilities include, but are not limited to:

• Conduct the entire study visit for each patient, ensuring that the protocol is followed, which requires an in-depth understanding of the intricacies of each individual protocol and patient needs.

• Maintain a comprehensive functional knowledge of the ancillary departments to be involved in trial visits (e.g., Radiology, CRU), communicating and coordinating with such departments effectively.

• Perform his/her job maintaining patient confidentiality at all times, adhering to the university requirements for the conduct of clinical research.

• Oversee regulatory maintenance, adherence with ongoing training requirements, accurate reporting of clinical trial visits via the OnCore/CTMS system, accurate and timely data entry, accurate and timely reporting of adverse events, and timely communication with team members/clinical trial sponsors.

• Coordinate the ALL ALS studies, which will be conducted at the Georgetown University Hospital Dept. of Neurology main site and with remote patients.

• Spend 5 days per week on site for these trials, which is a new national natural history/biobanking study with 35 sites around the country.

• Interact with other coordinators around the country on regular meetings and follow a central IRB protocol for all sites.

Work Interactions
As an employee of Georgetown University, the CRC2 directly supports the University’s mission of cura personalis. Clinical Trials offer a unique opportunity for a patient to receive personalized and comprehensive care in a manner that they may not experience otherwise as a patient. Per the requirements of each clinical trial protocol, the CRC2 is required to be the main point of contact for a patient in a clinical trial and must respond to inquiries from any patient within 24 hours. The CRC2 is instructed and required to maintain regular contact with each patient in their respective trials, because it is an FDA requirement to report adverse events in a timely manner, no matter the severity. As such, clinical trial patients develop close relationships with the CTM/CRC for a trial, which provides unprecedented access to care when necessary. In the overall scheme of the Georgetown University Medical Center, this position indirectly and directly coordinates with multiple divisions/departments such as the Clinical Research Operations Office (CROO), the Clinical Research Unit (CRU), Research Pharmacology, the Radiology Department, Department of Medicine, Dermatology, Ophthalmology, Pathology, and Gastroenterology.
 

On a daily basis, the CRC2 will report to one of the following: Study