Clinical Research Coordinator II

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
* *** Job Overview
** 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 Multiple Sclerosis (MS), Stroke, and Parkinson’s Disease. 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 CRC2 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.

The CRC2 must maintain a comprehensive functional knowledge of the ancillary departments to be involved in trial visits (e.g., Radiology, CRU, Cardiology) and must be able to communicate and coordinate with such departments effectively. The CRC2 must be capable of performing his/her job maintaining patient confidentiality at all times, and must adhere to the university requirements for the conduct of clinical research.

Additional job requirements include, but are not limited to: 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.

The CRC II for this position will is responsible for coordinating 7 MS studies which will be conducted at the Georgetown University Hospital Dept. of Neurology main site. The CRC II will spend 5 days per week on site for these trials. The incumbent will spend 5 days per week on site for these trials. The CTM will meet project deadline expectations, be proficient multitasker, patient-oriented and have the ability to prioritize tasks.
** Work Interactions
** As an employee of Georgetown University, the CRC II 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 CRC II 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 CRC II 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  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 CRC II 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.

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