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Requirements

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

The Clinical Research Coordinator 2 (CRC2) manages and coordinates 7 of approximately 55 ongoing clinical trials, Phases I-IV in the Department of Neurology, primarily in the disease states of Multiple Sclerosis (MS), Amyotrophic Lateral Sclerosis (ALS), Generalized Myasthenia Gravis (gMG) and Spinal Muscular Atrophy (SMA). Coordination and management of such studies is both a dynamic and demanding responsibility that requires refined technical, organization, interpersonal, and coordination skills. They are 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 conducts 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 maintains a comprehensive functional knowledge of the ancillary departments to be involved in trial visits (e.g., Radiology, CRU, and Cardiology), and communicates and coordinates with such departments effectively. They maintain patient confidentiality at all times, and adhere to the university requirements for the conduct of clinical research. Additional job requirements include but are not limited to regulatory maintenance, adherence to 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, and timely communication with team members and clinical trial sponsors.

The CRC2 coordinates 6 MS, ALS, gMG, & SMA trials, which are conducted within the Department of Neurology at Georgetown University Medical Center (main site) or at either of our local satellite clinics - Chevy Chase, MD or McLean, VA. As the only Center Coordinator who works exclusively in these disease states for these specific trails, they have unique coordination of these trials and spend 5 days a week on site.

Work Interactions and Work Mode Designation

As an employee of Georgetown University, the CRC2 directly supports the University’s mission of cura personalis – care for the 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 required to serve as the main point of contact for a patient in a clinical trial and must respond to inquiries from any patient within 24 hours. Additionally, because it is an FDA requirement to report adverse events in a timely manner, no matter the severity, the CRC2 is instructed and required to maintain regular contact with each patient in their respective trials. 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, 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.

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/CRC II (including the CRC2), 2 Associate Directors, the Director of Clinical Trials, and up to 5 student hires. They are responsible for managing at least 7 trials or our department’s overall portfolio of approximately 55 ongoing trials. While the CRC2’s primary direct report is the Associate Director of Clinical Trials, they 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). Both the Associate Director and the Director of Clinical Trials rely on timely responses from the CTM/CRC II staff 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 CRC2’s portfolio requires ongoing communication with patients currently enrolled in each trial. Therefore, the CRC2 participates timely in a myriad of interactions – for example, answers questions from patients in their portfolio, triages issues as they arise, facilitates communication between the PI/Sub-Is and patients for adverse events and clinical concerns, schedules future visits, sends reminders for upcoming visit, ensures that the timing of the visit will work for any PIs/Sub-Is involved, and reschedules 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 positions can be found on the Department of Human Resources website: https://hr.georgetown.edu/mode-of-work-designation.

Qualifications

• Bachelor’s degree [note: consideration will be given to 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 interaction, in a full time, part time, or extensive volunteer experience – preference for experience as a Clinical Trial Coordinator, Clinical Research Assistant, or equivalent position. However, as this is a niche area of expertise, candidates with at least 2 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). Ideal work experience is with Neurology patients - specifically in the MS and neuromuscular clinics – which provided an understanding of the unique characteristics of these disease states and 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 process and ship laboratory samples independently

• Experience with phlebotomy experience and in accessing and reading patient medical records

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

• High detail orientation and organization

• Ability to follow directions and to work respectfully in a team

• High motivation and commitment to providing exceptional service

• Ability to demonstrate moral and ethical responsibility and maintain professionalism at all times

• Excellent communication skills with respect to both external communication (patients, sponsors, sponsor affiliates) and internal communication (supervisors, team members, PI, Sub-Is, ancillary department) - specifically, ability to provide written communication that is clear, detailed, and free of errors – and verbal communication that is clear, relevant, and respectful at all times

• Current CITI Group 1 Biomedical, HIPAA, and IATA Training

• Exposure to/experience handling human biological specimens, and ability to operate a centrifuge and to process and ship laboratory samples independently

• Phlebotomy experience

• Experience accessing and reading patient medical records

• A general working knowledge of medical care/medical operations and regulations

• High detail orientation and well organized

• Ability to follow directions and to work respectfully in a team

• High motivation and commitment to providing exceptional service

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EEO Statement:

Georgetown University is an Equal Opportunity/Affirmative Action Employer (https://policymanual.hr.georgetown.edu/https%3A//policymanual.gudrupal.georgetown.edu/201-Equal-Employment-Opportunity-Affirmative-Action) 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 (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .

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 (https://benefits.georgetown.edu/staff/enrolling/) .

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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 (https://benefits.georgetown.edu/staff/enrolling/) .