Clinical Research Coordinator 2, Department of Neurology – Georgetown University Medical Center Job at Georgetown University
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Requirements
Clinical Research Coordinator 2, Department of Neurology – Georgetown University Medical Center Job Overview
Job Overview
The Clinical Research Coordinator 2 (CRC2) is responsible for managing and coordinating seven of approximately 50 ongoing clinical trials, Phases I-IV, in the Department 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.
They are responsible for learning the schedule of assessments for each trial, and for coordinating each visit, which involves extensive preparatory work/pre-visit planning. At the time of the visit, the CRC2 conducts 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 maintains a comprehensive functional knowledge of the ancillary departments to be involved in trial visits (e.g., Radiology, CRU, Cardiology), and communicates and coordinates with such departments effectively. They maintain patient confidentiality at all times, and 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.
Prioritizing and completing projects with minimal supervision, the CRC2 coordinates five MS studies and two Stroke studies conducted at the Georgetown University Hospital’s Department of Neurology main site, Chevy Chase, MD, and McLean, VA, spending five days per week on site for these trials.
Work Interactions
As an employee of Georgetown University, the CRC2 directly supports the University’s mission of
cura personalis – “care for the whole person.” 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, they are 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, the CR2 indirectly and directly supports multiple departments. Operationally, they coordinate 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 CR2 indirectly supports research-related operations in departments ancillary to Neurology.
Reporting on a daily basis to the Associate Director of Clinical Trials, the CR2 is a member of a robust team comprised of 6 CTM/CRC II s (including the CRC2), the Associate Director, the Director of Clinical Trials, and up to 4 student hires.
While the CRC2’s primary direct report is to the Associate Director of Clinical Trials, the CRC II also provides 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 Director and the Director of Clinical Trials rely on timely responses from the CTM/CRC IIs and Director of Clinical Trials in order to effectively execute their responsibilities.
On a regular basis (daily, weekly, or monthly, depending on the trial), the CRC2 communicates with patients currently enrolled in each trial; and responds to questions from patients in their portfolio in a timely manner; triages issues as they arise; facilitates communication between the PI/Sub-Is and patients for adverse events and clinical concerns; schedules future visits; sends reminders for upcoming visits; ensures that the timing of the visit will work for any PIs/Sub-Is involved, and reschedule when necessary.
Qualifications
- Bachelor’s degree, at minimum. Rare exceptions may be made for a candidate with an Associate’s Degree and at least 5 years of work experience as a Clinical Trial Coordinator or Clinical Research Assistant
- At least 2 years of experience working in a clinical setting that involves direct patient interaction, in a full time, part time, or extensive volunteer experience – preference for experience as a Clinical Trial Coordinator, Clinical Research Assistant, or equivalent position. However, as this is a niche area of expertise, candidates with at least 2 years of 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 work experience is with Neurology patients - specifically in the MS and Movement Disorder clinics. Candidates must have demonstrable knowledge of their experience working with such patients; an understanding of the unique characteristics of these disease states; and experience with regulatory maintenance, preparation, and IRB submission activities.
- Current CITI Group 1 Biomedical, HIPAA, and IATA Training
- Exposure to/experience with handling human biological specimens, and abilities to operate a centrifuge and to process and ship laboratory samples independently
- Experience in Phlebotomy and in accessing and reading patient medical records
- General working knowledge of medical care/medical operations and regulations
- Clinical experience measuring vital signs (Blood Pressure, Respiratory Rate, Temperature, Height, Weight), administering EKGs, performing PFTs and obtaining patient medical histories (e.g., know how to read a medical record, to determine which information in the medical record needs to be captured in the patient’s research record, and how to ask both doctors and patients to clarify ambiguous information in a medical record)
- Highly detail orientation and well organized
- Ability to follow directions and to work respectfully within a team
- High motivation and commitment to providing exceptional service
- Ability to demonstrate moral and ethical responsibility and maintain professionalism at all times Excellent communication skills with respect to external communication (patients, sponsors, sponsor affiliates) and to internal communication (supervisors, team members, PI, Sub-Is, ancillary department)
- Strong ability to provide both written communications that are clear, detailed, and free of errors, and verbal communications that are clear, relevant, and respectful at all times
Work Mode: On-Campus. Please note that work mode designations are regularly reviewed in order to meet the evolving needs of the University. Such review may necessitate a change to a position’s mode of work designation. Complete details about Georgetown University’s mode of work designations for staff and AAP positions can be found on the Department of Human Resources
Mode of Work Designation
.
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Benefits:
Georgetown University offers a comprehensive and competitive benefit package that includes medical, dental, vision, disability and life insurance, retirement savings, tuition assistance, work-life balance benefits, employee discounts and an array of voluntary insurance options. You can learn more about benefits and eligibility on the
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