Clinical Research Coordinator II

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

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

• P recise and prompt data entry, timely reporting of adverse events, and consistent communication with team members and trial sponsors

Work Interactions

This role specifically entails coordinating 7 studies conducted at the Georgetown University Hospital Department of Neurology main site, necessitating a full-time on-site presence, totaling 5 days per week. The ideal candidate will meet project deadlines, excel in multitasking, prioritize tasks effectively, and demonstrate a patient-centric approach.

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 CRCII 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 CRCII 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 CRCII will report to the Associate Director of Clinical Trials. The CRCII is part of a robust team comprised of 6 CTM/CRCII s (including the CRCII), the Associate Director, the Director of Clinical Trials, and up to 4 student hires. The CRCII is responsible for managing at least 7 trials out of the overall portfolio of approximately 55 ongoing trials within our specific department. While the CRCII’s primary direct report is to the Associate Director of Clinical Trials, the CRCII 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).

Requirements and Qualifications

• Bachelor’s degree, at minimum

• 5 years’ minimum work experience as a Clinical Trial Coordinator or Clinical Research Assistant Trial Coordinator, Clinical Research Assistant, or equivalent position2 year min. experience will be as a Clinical

• 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)

• Must have experience working with Neurology patients 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

• Must 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

• 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 (e.g., knows how to read a patient’s research record, and knows how to ask both doctors and patients to clarify ambiguous information medical record and is able to determine which information in the medical record needs to be capture in the

• in a medical record)

The CRCII 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.

Work Mode Designation

This position has been designated as 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 website: .

Pay Range:

The projected salary or hourly pay range for this position which represents the full range of anticipated compensation is:

$44,022.00 - $73,406.80

Compensation is determined by a number of factors including, but not limited to, the candidate’s individual qualifications, experience, education, skills, and certifications, as well as the University’s business needs and external factors.

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EEO Statement:

GU is an Equal Opportunity Employer ( . All qualified applicants are encouraged to apply, and will receive consideration for employment without regard to age, citizenship, color, disability, family responsibilities, gender identity and expression, genetic information, marital status, matriculation, national origin, race, religion, personal appearance, political affiliation, sex, sexual orientation, veteran status, or any other characteristic protected by law ( .

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 ( .