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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 Stroke, Multiple Sclerosis (MS), Stroke, and neuromuscular 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 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 CRC2 will report to the Associate Director of Clinical Trials. The CRC2 is part of a robust team comprised of 7 CTM/CRC II s (including the CRC2), the Associate Directors, the Director of Clinical Trials, and up to 4 student hires. The CRC2 is responsible for managing at least 7 trials out of the overall portfolio of approximately 55 ongoing trials within our specific department. While the CRC2'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 CRC2's portfolio requires ongoing communication with patients currently enrolled in each trial. The CRC2 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.
Requirements and Qualifications
The candidate should have a Bachelor's degree, at minimum. Rare exceptions may be made for a candidate with an Associate's Degree and 5 years' minimum work experience as a Clinical Trial Coordinator or Clinical Research Assistant. In addition to a B.A./B.S. or A.A + 5 year CTC experience, the CRC2 must have at least 3 years of experience working in a clinical setting that involves direct patient interaction, in a full time, part time, or extensive volunteer experience. The ideal candidate's 2 year min. experience will be as a Clinical Trial Coordinator, Clinical Research Assistant, or equivalent position. However, as this is a niche area of expertise, candidates with at least 3 years' work experience in the following areas will be considered: human subjects research (e.g., working in a lab or on studies for PhD candidates at an academic institution), social work, nursing, occupational health, Emergency Medical Technician, or ancillary departments that directly support Clinical Trials (e.g., the GUMC Clinical Research Operations Office or Clinical Research Unit).
The ideal candidate for this specific position must have experience working with Neurology patients, specifically in the MS and neuromuscular clinics. The candidate must be able to demonstrate knowledge of their experience working with such patients and possess an understanding of the unique characteristics of these disease states. The candidate should also have previous experience with regulatory maintenance, preparation, and IRB submission activities.
The CRC2 must have current CITI Group 1 Biomedical, HIPAA, and IATA Training. He/She must also have previous exposure to/experience handling human biological specimens; must be able to operate a centrifuge and be capable of processing and shipping laboratory samples independently. Must have phlebotomy experience. The candidate must have previous experience accessing and reading patient medical records and must have a general working knowledge of medical care/medical operations and regulations. Must have clinical experience measuring vital signs (Blood Pressure, Respiratory Rate, Temperature, Height, Weight), administering EKGs, performing PFTs and obtaining patient medical histories (e.g., knows how to read a medical record and is able to determine which information in the medical record needs to be capture in the patient's research record, and knows how to ask both doctors and patients to clarify ambiguous information in a medical record).
The CRC2 must be highly detail oriented, organized, able to follow directions, able to work respectfully in a team, highly motivated, and committed to providing exceptional service. The candidate must be able to demonstrate moral and ethical responsibility and maintain professionalism at all times. He/She must have excellent communication skills with respect to external communication (patients, sponsors, sponsor affiliates) and internal communication (supervisors, team members, PI, Sub-Is, ancillary department). Specifically, written communication must be clear, detailed, and free of errors. Verbal communication must be clear, relevant, and respectful at all times.
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