Clinical Research Coordinator II

Georgetown University

1d•$44,022 - $73,407•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. Job Overview As an employee of Georgetown University, the CRCII 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 CRCII 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 CRCII 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. The Associate Director and the Director of Clinical Trials rely on timely responses from the CTM/CRCII 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 CRCII’s portfolio requires ongoing communication with patients currently enrolled in each trial. The CRCII 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. The role of Clinical Research Coordinator II (CRCII) encompasses the management and coordination of a subset of ongoing clinical trials within the Department of Neurology, totaling approximately 7 out of 55 trials spanning Phases I-IV. These trials predominantly focus on neuroimmunology and neuromuscular diseases. The CRCII is entrusted with mastering the schedule of assessments for each trial and meticulously planning and coordinating every visit. This involves extensive preparatory work detailed in the "Responsibilities" section. During patient visits, the CRCII assumes responsibility for conducting the entire study visit, ensuring strict adherence to protocol. This necessitates an intimate understanding of each protocol's nuances and attending to individual patient needs. Furthermore, the CRCII must possess a thorough understanding of ancillary departments involved in trial visits, such as Radiology, CRU, and Cardiology. Effective communication and coordination with these departments are essential. Upholding patient confidentiality and adhering to university standards for clinical research conduct are paramount. Additional duties include, but are not limited: Regulatory maintenance, compliance with ongoing training mandates Accurate reporting of clinical trial visits via the OnCore/CTMS system Precise and prompt data entry, timely reporting of adverse events, and consistent communication with team members and trial sponsors

Requirements

Bachelor’s degree
At least 5 years’ minimum work experience as a Clinical Trial Coordinator or Clinical Research Assistant
2 years minimum experience as a Clinical Trial Coordinator, Clinical Research Assistant, or equivalent position
At least 3 years’ work experience in 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 and possess an understanding of the unique characteristics of these disease states
Must have previous experience with regulatory maintenance, preparation, and IRB submission activities
Must have current CITI Group 1 Biomedical, HIPAA, and IATA Training
Must 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
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
Highly detail oriented
Organized
Able to follow directions
Able to work respectfully in a team
Highly motivated
Committed to providing exceptional service
Able to demonstrate moral and ethical responsibility
Maintain professionalism at all times
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.
Verbal communication must be clear, relevant, and respectful at all times.

Responsibilities

Manage and coordinate a subset of ongoing clinical trials within the Department of Neurology, totaling approximately 7 out of 55 trials spanning Phases I-IV, predominantly focusing on neuroimmunology and neuromuscular diseases.
Master the schedule of assessments for each trial and meticulously plan and coordinate every visit.
Conduct the entire study visit, ensuring strict adherence to protocol.
Possess a thorough understanding of ancillary departments involved in trial visits, such as Radiology, CRU, and Cardiology, and coordinate effectively with them.
Uphold patient confidentiality and adhere to university standards for clinical research conduct.
Perform regulatory maintenance.
Comply with ongoing training mandates.
Accurately report clinical trial visits via the OnCore/CTMS system.
Perform precise and prompt data entry.
Timely report adverse events.
Maintain consistent communication with team members and trial sponsors.
Respond to patient inquiries within 24 hours.
Maintain regular contact with each patient in their respective trials.
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 visits.
Ensure that the timing of the visit will work for any PIs/Sub-Is involved.
Reschedule visits when necessary.