The CRC2 for this position will is responsible for coordinating 7 Neurology trials which will be conducted at the Georgetown University Hospital Dept. of Neurology main site. The CRC2will spend 5 days per week on site for these trials. The CRC2 will be the only coordinator for the neuromuscular trials at our center who works exclusively in these disease states and therefore has a unique knowledge of the coordination for these trials.
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 CRC will report to the Director of Clinical Trials. The CRC is part of a robust team comprised of 7 CTM/CRC s (including the CRC), social worker, research fellow, Nurse Practitioner, the Director of Clinical Trials, along with up to 4 student hires. The CRC is responsible for managing at least 7 trials out of the overall portfolio of approximately 55 ongoing trials within our specific department. While the CRC’s primary direct report is to the Associate Director of Clinical Trials, the CRC II will also provide project-specific deliverables to others such as, the Director of Clinical Trials, the PI for each trial, and to the sponsor contact (e.g., the study monitor appointed by the sponsor for each trial). The Associate Directors and the Director of Clinical Trials rely on timely responses from the CTM/CRC II s and Director of Clinical Trials in order to effectively execute their responsibilities.
On a regular basis (daily, weekly, or monthly, depending on the trial), management of the trials within the CRC’s portfolio requires ongoing communication with patients currently enrolled in each trial. The CRC must respond to questions from patients in their portfolio in a timely manner; triage issues as they arise, facilitate communication between the PI/Sub-Is and patients for adverse events and clinical concerns, schedule future visits, send reminders for upcoming visit, ensure that the timing of the visit will work for any PIs/Sub-Is involved, reschedule when necessary, etc.