Clinical Trials Manager – Department of Neurology – Georgetown University Medical Center

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Requirements

Clinical Trials Manager – Department of Neurology – Georgetown University Medical Center

Georgetown University Medical Center’s Department of Neurology is dedicated to three major goals: Neurological education of students, residents and physicians, advancement of our scientific knowledge via research which will improve the diagnosis and treatment of neurological disorders, and delivery of cutting edge neurological care to our patients.

Job Overview

The Clinical Trials Manager (CTM) is responsible for managing and coordinating 7 out of approximately 55 ongoing Depart of Neurology clinical trials, Phases I-IV, primarily in the disease states of Multiple Sclerosis (MS). Coordination and management of such studies is both a dynamic and demanding responsibility that requires refined technical, organization, interpersonal, and coordination skills.

The CTM is responsible for learning the schedule of assessments for each trial, and for coordinating each visit, which involves extensive preparatory work/pre-visit planning. At the time of the visit, they conduct 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 CTM maintains a comprehensive functional knowledge of the ancillary departments to be involved in trial visits – for example, Radiology, CRU, 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 in all additional job requirements -  include but are not limited to regulatory maintenance, adherence with ongoing training requirements, accurate reporting of clinical trial visits in 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 CTM coordinates 7 MS studies, which are conducted at both the Georgetown University Medical Center’s Department of Neurology and our Chevy Chase, MD satellite office. They spend 5 days per week on site for these trials – ably meeting project deadline expectations, proficiently multitasking, maintaining a patient orientation and prioritizing tasks.

Work Interactions

As an employee of Georgetown University, the Clinical Trials Manager 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 CTM serves as the main point of contact for a patient in a clinical trial and responds to inquiries from any patient within 24 hours. As instructed and required, they maintain regular contact with each patient in their respective trials, reporting 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.

Operationally, the CTM 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.

Reporting on a daily to the Associate Director of Clinical Trials, the CTM also provides 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). The Associate Director and the Director of Clinical trials rely on timely responses from the CTM/CRC II s in order to effectively execute their responsibilities.

Further, they are a member of a robust team comprised of 6 CTM/CRC IIs (including the incumbent), an Associate Director, the Director of clinical trials, and as many as 4 student hires. As well, they manage at least 7 trials of the overall portfolio of approximately 55 ongoing trials within our specific department.

On a regular basis (daily, weekly, or monthly, depending on the trial), the CTM maintains ongoing communication with patients currently enrolled in each trial; and responds to questions from patients in their portfolio in a timely manner; 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.

Qualifications

• Bachelor’s degree is required, though rare exceptions 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 interaction, in a full time, part time, or extensive volunteer experience – preference for at least two of those years as a Clinical Trial Coordinator, Clinical Research Assistant, or equivalent position. However, as this is a niche area of expertise, candidates with at least 3 years or work experience in the following areas will be considered: human subjects research – for example, 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 – for example, the GUMC Clinical Research Operations Office or Clinical Research Unit
• Demonstrable knowledge gained from their experience working with such patients and an understanding of the unique characteristics of these diseases
• 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
• 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, and obtaining patient medical histories – for example,  knows how to read a medical record and to determine which medical record information to capture in the patient’s research record, and to ask both doctors and patients to clarify ambiguous information in a medical record.
• High detail orientation, well organized, and 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 to maintain professionalism at all times
• Excellent communication skills with respect to external communication (patients, sponsors, sponsor affiliates) - and internal communication (manager, team members, PI, Sub-Is, ancillary department)
• Ability to provide written communication that is clear, detailed, and free of errors and to provide verbal communication that is clear, relevant, and respectful at all times

Preferred qualification

Experience working with Neurology patients

Work Mode: 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 Mode of Work Designation .

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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 .

COVID-19 Vaccination Requirements:

The Georgetown University community is committed to our public health approach and the important role that vaccines play in contributing to the safety of our University and our broader communities. Georgetown University requires students, faculty, staff and visitors to be fully vaccinated against COVID-19 and to have received a COVID-19 vaccine booster shot when eligible, or to have an approved medical or religious exemption. This requirement applies to all faculty and staff, including teleworking employees. Complete details and updates can be found in the Coronavirus (COVID-19) Resource Center .