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The Clinical Research Coordinator II (CRC II) is responsible for managing and coordinating 4-6 out of approximately 30 ongoing clinical trials, Phases I-IV, in the Dept. of Neurology, primarily in the disease states of Multiple Sclerosis, Parkinson Disease, Headache, Stroke, ALS, and Epilepsy. S/he learns the schedule of assessments for each trial, and coordinates each visit, which involves extensive preparatory work/pre-visit planning described in the "Responsibilities" section. Reporting to the Director of Clinical Trials, the CRC II has additional duties that include but are not limited to:
Maintains a comprehensive functional knowledge of the ancillary departments to be involved in trial visits (such as Radiology, CRU, and Cardiology), communicating and coordinating with such departments effectively.
Maintains patient confidentiality at all times, adhering to the university requirements for the conduct of clinical research.
Oversees regulatory maintenance, adherence with ongoing training requirements, and accurate reporting of clinical trial visits via the OnCore/CTMS system.
Ensures accurate and timely data entry, accurate and timely reporting of adverse events, and timely communication with team members and clinical trial sponsors.
Coordinates 3 Parkinson Disease studies and 1 epilepsy trial, with specific trial assignments changing based on study timelines.
Maintains 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.
indirectly and directly supports multiple departments, such as the Clinical Research Operations Office (CROO), the Clinical Research Unit (CRU), the Research Pharmacy, the Radiology Department, Ophthalmology, and Gastroenterology.
Manages 4-6 trials out of the overall portfolio of approximately 30 ongoing trials within our specific department.
Provides project-specific deliverables to others such as the PI for each trial, and to the sponsor contact (the study monitor appointed by the sponsor for each trial), and to the Regulatory Manager.
Responds to questions from patients in their portfolio in a timely manner.
Triages issues as they arise, facilitating communication between the PI/Sub-Is and patients for adverse events and clinical concerns.
Schedules future visits, sends reminders for upcoming visit, and ensures that the timing of the visit will work for any PIs/Sub-Is involved, rescheduling when necessary.
Bachelor's Degree, or an Associate's Degree and 5 years' minimum work experience as a Clinical Trial Coordinator
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
At least 2 years' work experience in the following areas will be considered: human subjects research, social work, nursing, occupational health, Emergency Medical Technician, or ancillary departments that directly support Clinical Trials
Experience working with Neurology patients in some capacity
Ability to demonstrate knowledge of their experience working with such patients and possess an understanding of the differences between neurological disorders such as Parkinson Disease, Multiple Sclerosis, and epilepsy
Current CITI Group 1 Biomedical, HIPAA, and IATA Training with previous exposure to/experience handling human biological specimens
Previous experience accessing and reading patient medical records and must have a general working knowledge of medical care/medical operations and regulations
Basic clinical experience measuring vital signs (Blood Pressure, Respiratory Rate, Temperature, Height, Weight), administering EKGs, and obtaining patient medical histories
Highly detail oriented, organized, able to follow directions, able to work respectfully in a team, highly motivated, and committed 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 and internal communication, with written communication being clear, detailed, and free of errors
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Internal Number: JR07293
About Georgetown University
Established in 1789, Georgetown is the nation's oldest Catholic and Jesuit University. Georgetown is one of the world's leading academic and research institutions, offering a unique educational experience that prepares the next generation of global citizens to lead and make a difference in the world.