Clinical Research Coordinator 2 - Georgetown University Medical Center

Georgetown University comprises two unique campuses in the nation’s capital. With the Hilltop Campus located in the heart of the historic Georgetown neighborhood, and the Capitol Campus, just minutes from the U.S. Capitol and U.S. Supreme Court, Georgetown University offers rigorous academic programs, a global perspective, and unparalleled opportunities to engage with Washington, D.C. Our community is a close-knit group of remarkable individuals driven by intellectual inquiry, a commitment to social justice, and a shared dedication to making a difference in the world.

Requirements

The Clinical Research Coordinator 2 (CRC2) is responsible for managing and coordinating 7 out of approximately 55 ongoing clinical trials, Phases I-IV, in the Dept. of Neurology, primarily in the disease states of Migraine/Headache, Parkinson’s Disease, and Neuromuscular Trials. 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 described in the “Responsibilities” section. At the time of the visit, the CTM is responsible for conducting 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. Additional duties include, but are not limited to:

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

• Perform their 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 and clinical trial sponsors.

• Coordinate 7 migraine/headache, PD, and Neuromuscular trials which will be conducted at the Georgetown University Hospital Dept. of Neurology satellite clinic in McLean,VA, Chevy Chase. MD or at the Georgetown University Hospital Dept. of Neurology main site.

• Spend 5 days per week on site for these trials as the only coordinator for migraine/headache trials at our center, working exclusively in this disease state.

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 supports multiple departments. From a fiscal perspective, the indirect/overhead costs generated by clinical trials support the GUMC operating costs. Without an experienced CRC2 in this position, we cannot participate in the trials specified in this application, and/or future clinical trials, which would significantly hurt the revenue that these trials generate. This would be detrimental to the ongoing clinical trial operations at our site. Operationally, the CRC2 coordinates with other departments such as the Clinical Research Operations Office (CROO), the Clinical Research Unit (CRU), the Research Pharmacy, the Radiology Department, Department of Medicine, Dermatology, Ophthalmology, and Gastroenterology. By interacting with other departments within the GUMC, the position indirectly supports research-related operations in departments ancillary to Neurology.

On a daily basis, the CRC2 will report to the Associate Director of Clinical Trials. The CRC2 is part of a robust team of 6 CTM/CRC II s (including the CRC2), 2 Associate Directors, the Director of Clinical Trials, and up to 5 student hires. The CRC2 is responsible for managing at least 7 trials out of the over