Director of Clinical Trials for Neuroimmunology, Neuro-Oncology, and Neuromuscular Diseases - Georgetown University Medical Center

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Requirements

Director of Clinical Trials for Neuroimmunology, Neuro-Oncology, and Neuromuscular Diseases - Georgetown University Medical Center

Job Overview

The Director of Clinical Trials for Neuroimmunology, Neuro-Oncology, and Neuromuscular Diseases serves as the primary point of contact for research coordinators involved in these areas, overseeing the entire process of research study conduct. They also act as the main contact for trial monitors and vendors.

In their role as Co-Director, they contribute to the completion of feasibility questionnaires and financial analyses for both sponsor-funded and investigator led trials. They provide oversight and management for approximately 40+ ongoing industry-sponsored clinical trials and investigator led trials, phases I-IV, in the Department of Neurology, in the following disorders and disease states: Neuroimmunology (MS, NMOSD, MOGAD) Neuro-Oncology, and Neuromuscular Disorders (ALS, DMD, BMD, SMA, and others).

They have unique knowledge of the coordination for these trials and the existing relationships with patients already enrolled in the studies. The Director must ensure that the team is adhering to all university requirements set forth by the Office of Research Quality Assurance (ORQA) and the Institutional Review Board (IRB), along with all applicable sponsor, state, and federal requirements for the conduct of clinical research.

The Co-Director provides oversight and management for approximately 40+ ongoing industry-sponsored clinical trials and investigator led trials, phases I-IV, in the Dept. of Neurology, in the following disorders and disease states: Neuroimmunology (MS, NMOSD, MOGAD) Neuro-Oncology, and Neuromuscular Disorders (ALS, DMD, BMD, SMA, and others). The Co-Director has a unique knowledge of the coordination for these trials and existing relationship with patients already enrolled in the studies. The Director must ensure that the team is adhering to all university requirements set forth by the Office of Research Quality Assurance (ORQA) and the Institutional Review Board (IRB), along with all applicable sponsor, state, and federal requirements for the conduct of clinical research.

The Co-Director is the main point of contact for all ancillary services within the institution. Coordination and management of the aforementioned team and interaction with these departments requires management experience, in-depth knowledge and understanding of Neurology and clinical trials, strong interpersonal skills, strong analytical and problem-solving skills, the ability to personally manage and oversee several projects at one time.

The Director coordinates all sponsor monitoring visits for trials under their management; and ensures all follow up/action items noted during a monitoring visit are completed before the next scheduled monitoring visit.

As well, they help with financial analysis for the department to ensure that all staff under their management is meeting requirements for their allotted salary; and meet with Investigators to ensure they are being properly reimbursed for the efforts on their respective clinical trials.

They serve as part of the financial communication between the University and respective trial payors; and during the start-up process, they are engaged with the completion of feasibility questionnaires with Principal Investigators.

In addition to their own job responsibilities, the Director is fully capable of and proficient in performing the same tasks as the team that they manage. Therefore, they maintain comprehensive functional knowledge of the ancillary departments to be involved in trial visits (e.g., Radiology, CRU, Cardiology) and communicate and coordinate with such departments effectively.

The Director maintains patient confidentiality at all times, and adheres to the University’s requirements for the conduct of clinical research, to include but not limited to regulatory maintenance, adherence with ongoing training requirements, review of source documents created by team members, 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.

Work Interactions and Work Mode Designation

As an employee of Georgetown University, the Director of Clinical Trials 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. The Director is responsible for ensuring these interactions take place in accordance with all applicable regulations and sponsor agreements.

On a daily basis, they report to the Chairman of the Department of Neurology; and interacts with each of the employees whom they supervise – and with clinical trial sponsors, monitors, principal investigators, and sub-investigators.

On a regular basis, they Director interacts with

• Clinical Research Unit (CRU) re administration of duties performed for ongoing Neurology studies; applications for new studies requiring CRU services and invoices sent by the CRU.
• Office of Research Quality Assurance (ORQA): Participates in regular meetings with the ORQA and the Clinical Research Network to maintain a current working knowledge of ORQA policies - as well as a working group to develop and advise on Standard Operating Procedures
• MedStar-Georgetown University Hospital (MGUH): Department of Radiology & Department of Pathology &  Laboratory Medicine: ensures that new study protocols requiring radiology services are sent and completed by the appointed staff, and that appropriate staff complete proper reimbursement from GUMC to MGUH for services
• MGUH Research Pharmacy: submits new study protocols requiring drug dispensation, obtains and maintains required records, ensures submission and ensures proper staff receive invoices for pharmacy effort on clinical trials
• MGUH Department of Neurology Leadership: meets regularly with leadership and business administrators to maintain a current working knowledge of departmental procedures and SOPs to ensure staff compliance with required procedures at GU main campus and satellite clinics at McLean and Chevy Chase
• Human Resources: submits hiring forms for new staff and students when needed, as well PD renewals for staff on an annual basis, submit annual staff performance reviews; and ensures staff compliance with GUMC requirements and protocol

For the clinical trials for which the Director is the primary coordinator, the serves as the main point of contact for patients in the 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. Therefore, clinical trial patients develop close relationships with the CTM/CRC for a trial, which provides unprecedented access to care when necessary.

Furthermore, the Director directly managing as many as 5 to 6 clinical trial personnel, including Clinical Research Coordinators/Clinical Trial Managers, and 2 to 3 student hires.

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 as Director of Clinical Trials

• Bachelor’s degree
• At least 5 years of  related experience - preference for management/oversight experience, specifically in clinical trials
• Experience with clinical trial/research operations, clinical operations and care coordination, and strong working knowledge of ancillary hospital departments
• Ability to independently decisions regarding clinical trial processes, and associated procedures, such as the management of study drug and required work with ancillary hospital departments. Knowledge regarding submission of applications in OnCore/CTMS and the GU Institutional Review Board system
• Ability to maintain knowledge of current ORQA policies and to supervise and advise employees regarding those policies
• Excellent organizational communication skills
• Ability to work independently and collaboratively with investigators and subjects
• Attention to detail and self-direction
• Ability to independently manage several tasks and projects at one time, simultaneously providing consistent oversight and guidance to staff
• Confidence with making hiring, performance management, and termination decisions

Additional Requirements and Qualifications as Clinical Trial Coordinator/Manager

• Ability to maintain knowledge currency with CITI Group 1 Biomedical, HIPAA, and IATA Training
• Exposure to/experience handling human biological specimens
• Ability to independently operate a centrifuge and to process and ship laboratory samples independently
• Experience accessing and reading patient medical records and a general working knowledge of medical care/medical operations and regulations
• Clinical experience with measuring vital signs (Blood Pressure, Respiratory Rate, Temperature, Height, Weight), administering EKGs, and obtaining patient medical histories (e.g., knows how to read a medical record and to determine which information in the medical record needs to be capture in the patient’s research record; and knows how to ask both doctors and patients to clarify ambiguous information in a medical record)

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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 .