Clinical Research Coordinator 2, Department of Neurology - Georgetown University Medical Center

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Requirements

Clinical Research Coordinator 2, Department of Neurology - Georgetown University Medical Center

Georgetown’s Department of Neurology seeks to prevent, treat and cure cancers by linking scientific discovery, expert and compassionate patient care, quality education and partnership with the community - guided by the principle of cura personalis - care for others. We seek to improve the diagnosis, treatment, and prevention of cancer through innovative basic and clinical research, patient care, community education and outreach, and the training of cancer specialists for the future.

Job Overview

The role of Clinical Research Coordinator 3 (CRC2) 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 - which involves extensive preparatory work. During patient visits, the CRC2 assumes responsibility for conducting the entire study visit, ensuring strict adherence to protocol - which necessitates an intimate understanding of each protocol's nuances and attending to individual patient needs.

Furthermore, the CRC2 gains and maintains a thorough understanding of ancillary departments involved in trial visits, such as Radiology, CRU, and Cardiology. Therefore they must maintain effective communication and coordination with these departments, uphold patient confidentiality, and adhere to university standards for clinical research conduct.

Responsibilities also include 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.

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. Therefore, the CRC2 meets project deadlines, excels in multitasking, prioritizes tasks effectively, and demonstrates a patient-centric approach.

Work Interactions

As an employee of Georgetown University, the CRC2 directly supports the University’s mission of cura personalis – care of 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, the CRC2 is the main point of contact for a patient in a clinical trial and must respond to inquiries from any patient within 24 hours. As well, because it is an FDA requirement to report adverse events in a timely manner, no matter the severity, they maintain regular contact with each patient in their respective trials. As a result, clinical trial patients develop close relationships with the CRC2 for a trial, which provides unprecedented access to care when necessary. In the overall scheme of the Georgetown University Medical Center, the CRC2 indirectly and directly supports multiple departments. From a fiscal perspective, the indirect/overhead costs generated by clinical trials support the GUMC operating costs.

Operationally, the CRC2 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, they indirectly support research-related operations in departments ancillary to Neurology.

Work Interactions and Work Mode Designation

On a daily basis, the CRC2 reports to the Associate Director of Clinical Trials, and is a member of a robust team comprised of 6 CTM/CRC2s, the Associate Director, the Director of Clinical Trials.

The CRC2 manages at least 6 trials out of the overall portfolio of approximately 55 ongoing trials within our specific department. They provide project-specific deliverables to – in addition to the Associate Director - 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/CRC2 and Director of Clinical Trials in order to effectively execute their responsibilities. Therefore, on a regular basis (daily, weekly, or monthly, depending on the trial), the CRC2 engages in ongoing communication with patients currently enrolled in each trial – responding to questions from patients in their portfolio in a timely manner, triaging issues as they arise, and facilitating communication between the PI/Sub-Is and patients for adverse events and clinical concerns; and scheduling future visits, sending reminders for upcoming visit, ensuring that the timing of the visit will work for any PIs/Sub-Is involved, and rescheduling when necessary.

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: https://hr.georgetown.edu/mode-of-work-designation .

Requirements and Qualifications

• Bachelor’s degree - rare exception 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 3 years of experience working in a clinical setting that involves direct patient Interactions - ideally Neurology patients - in a full time, part time, or extensive volunteer experience – ideally with at least 2 of those years as a Clinical Trial Coordinator, Clinical Research Assistant, or an equivalent position [since this is a niche area of expertise, candidates with at least 3 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]

• Ability to demonstrate knowledge of their experience working with such patients and an understanding of the unique characteristics of these disease states
• Experience with regulatory maintenance, preparation, and IRB submission activities
• Current CITI Group 1 Biomedical, HIPAA, and IATA Training
• Exposure to/experience handling human biological specimens
• Ability to operate a centrifuge and to independently process and ship laboratory samples
• Phlebotomy experience
• Experience accessing and reading patient medical records and a 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. , knows how to read a medical record and ably determines which information in the medical record should be captured in the patient’s research record; and knows how to ask both doctors and patients to clarify any ambiguous entry in a medical record
• High detail orientation and ability to follow directions and to work respectfully in a team
• High motivation and commitment to providing exceptional service
• Commitment to moral and ethical responsibility and to 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) - specifically, written communication that is clear, detailed, and free of errors; and verbal communication that is clear, relevant, and respectful at all times

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Submission Guidelines:

Please note that in order to be considered an applicant for any position at Georgetown University you must submit a resume for each position of interest for which you believe you are qualified. Documents are not kept on file for future positions.

Need Assistance:

If you are a qualified individual with a disability and need a reasonable accommodation for any part of the application and hiring process, please click here  for more information, or contact the Office of Institutional Diversity, Equity, and Affirmative Action (IDEAA) at 202-687-4798 or [email protected] .

Need some assistance with the application process? Please call 202-687-2500. For more information about the suite of benefits, professional development and community involvement opportunities that make up Georgetown's commitment to its employees, please visit the Georgetown Works website .

EEO Statement:

Georgetown University is an Equal Opportunity/Affirmative Action Employer  fully dedicated to achieving a diverse faculty and staff.  All qualified applicants are encouraged to apply and will receive consideration for employment without regard to race, color, religion, national origin, age, sex (including pregnancy, gender identity and expression, and sexual orientation), disability status, protected 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 .