Clinical Research Coordinator 2 - Medical Center

Georgetown University • Vinalhaven, ME

8d • Onsite

About The Position

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 the ALL ALS studies, primarily in the disease states of Neuromuscular Disorders (ALS). 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) 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. The CRC2 for this position will is responsible for coordinating the ALL ALS studies which will be conducted at the Georgetown University Hospital Dept. of Neurology main site and with remote patients. The CRC2 will spend 5 days per week on site for these trials. This is a new national natural history/biobanking study with 35 sites around the country. The coordinator will interreact with other coordinators around the country on regular meetings and follow a central IRB protocol for all sites. It is not a treatment or blinded study. 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 Timely communication with team members and clinical trial sponsors. 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 coordinates with multiple divisions/departments such as the Clinical Research Operations Office (CROO), the Clinical Research Unit (CRU), Research Pharmacology, the Radiology Department, Department of Medicine, Dermatology, Ophthalmology, Pathology, and Gastroenterology. On a daily basis, the CRC2 will report to one of the following: Study PI, Study NP, and/or Associate Director of Clinical Trials. The CRC2 is part of a robust team comprised of approximately 7 CTM/CRC2s (including the CRC2), the Associate Directors, the Director of Clinical Trials, and up to 4 student hires. The CRC2 is responsible for managing the ALL ALS studies within our specific department. The CRC2 may also be asked to provide project-specific deliverables to other studies in the group, but additional studies will kept to a minimum and not the coordinator’s priority. The Study PIs, Associate Directors and the Director of Clinical Trials rely on timely responses from the CTM/CRC2s and Director of Clinical Trials 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

• Bachelor’s degree, at minimum 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.
• 2 year min. experience will be as a Clinical Trial Coordinator, Clinical Research Assistant, or equivalent position
• Candidates with at least 2-3 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).
• Must have experience working with Neurology patients, specifically in MS and neuromuscular clinics
• 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.
• Should also have previous experience with regulatory maintenance, preparation, and IRB submission activities.
• Must have current CITI Group 1 Biomedical, HIPAA, and IATA Training.
• 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
• May have phlebotomy experience
• Must have previous experience accessing and reading patient medical records and must have a general working knowledge of medical care/medical operations and regulations.
• Ideally have clinical experience measuring vital signs (Blood Pressure, Respiratory Rate, Temperature, Height, Weight, 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).
• 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
• Must be able to demonstrate moral and ethical responsibility and maintain professionalism at all times
• 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)
• Written communication must be clear, detailed, and free of errors, as well verbal communication must be clear, relevant, and respectful at all times.

Responsibilities

• managing and coordinating the ALL ALS studies
• learning the schedule of assessments for each trial
• coordinating each visit, which involves extensive preparatory work/pre-visit planning
• conducting the entire study visit for each patient, ensuring that the protocol is followed
• maintaining a comprehensive functional knowledge of the ancillary departments to be involved in trial visits (e.g., Radiology, CRU) and must be able to communicate and coordinate with such departments effectively
• maintaining patient confidentiality at all times
• adhering to the university requirements for the conduct of clinical research
• coordinating the ALL ALS studies which will be conducted at the Georgetown University Hospital Dept. of Neurology main site and with remote patients
• 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
• Timely communication with team members and clinical trial sponsors

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 Department of Human Resources website.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level