Director of Clinical Trials for Neurodegenerative Disorders, Neuromuscular, Stroke, Headache and Epilepsy Disorder - Georgetown University Medical Center

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Director of Clinical Trials for Neurodegenerative Disorders, Neuromuscular, Stroke, Headache and Epilepsy Disorder - Georgetown University Medical Center

Job Overview

The Director of Clinical Trials for Neurodegenerative Disorders, Stroke, Headache and Epilepsy Disorders serves as the primary point of contact for research coordinators involved in these areas, overseeing the entire process of research study conduct; and 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; and directly oversee and manage 5 to 66 clinical trial personnel, including Clinical Research Coordinators/Clinical Trial Managers, Research Assistant, and 1 to 2 student hires.

The Co-Director provides oversight and management for Neurology’s approximately 40+ ongoing industry-sponsored clinical trials and Investigator Led Trials, Phases I-IV, in the following disorders and disease states: Movement Disorders (which includes the but is not limited to the following disease states Parkinson’s Disease, LBD, Essential Tremor, and Multiple System Atrophy Headache disorders, Epilepsy, Stroke and Neuromuscular Disorders (ALS and Myasthenia Gravis).

They are the site manager for the Neurology’s satellite clinic in McLean, VA and has a unique knowledge of the coordination for these trials and existing relationship with patients already enrolled in the studies. They ensure that the team consistently adheres 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. They coordinate all sponsor monitoring visits for trials under their management; and ensure 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 members under their management meet the requirements for their allotted salary, and meet with Investigators to ensure they are being properly reimbursed for the efforts on their respective clinical trials. In addition, the Co-Director is part of the financial communication (though not responsible for) between the University and respective trial payors. During the start-up process, the Director is involved with the completion of feasibility questionnaires with Principal Investigators. (All start up documents will be completed by the Director of Clinical Trials.)

In addition to their own job responsibilities, they are fully capable of, and proficient in performing, the same tasks as the team they manage. Therefore, they maintain a comprehensive functional knowledge of the ancillary departments to be involved in trial visits (e.g., Radiology, CRU, Cardiology), and ably communicate and coordinate with such departments effectively; maintain patient confidentiality at all times; and adhere to the university requirements for the conduct of clinical research.

Additional duties include but are 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 On Core/CTMS system, accurate and timely data entry, accurate and timely reporting of adverse events, and timely communication with team members and clinical trial sponsors.

In addition to the Co-Director-specific duties, they also serve as Director for the department’s Center for Neurodegenerative Disorder’s clinical trials.

Work Interactions and Work Mode Designation

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

Reporting to the Chairman of the Department of Neurology, the Director of Clinical Trials interacts with each of the employees whom they supervise. In addition to oversight of the clinical trial coordinators/managers, the Director interacts daily with clinical trial sponsors, monitors, principal investigators, and sub-investigators; and regularly interacts with the following business units at GUMC:

• Clinical Research Unit (CRU): be aware of duties performed by CRU for ongoing Neurology studies, and to submit applications for new studies requiring CRU services. In addition to being aware of invoices sent by the CRU.
• Office of Research Quality Assurance (ORQA): participate in regular meetings with the ORQA and Clinical Research Network to maintain a current working knowledge of ORQA policies, and participate in a working group to develop and advise on Standard Operating Procedures
• MedStar-Georgetown University Hospital (MGUH) Department of Radiology and Department of Pathology & Laboratory Medicine: ensure that new study protocols requiring radiology services are sent and completed by the appointed staff, and ensure appropriate staff complete proper reimbursement from GUMC to MGUH for services
• MGUH Research Pharmacy: submit new study protocols requiring drug dispensation, obtain and maintain required records, ensure submission and ensure proper staff receives invoices for pharmacy effort on clinical trials
• MGUH Department of Neurology Leadership: meet 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: Submit hiring forms for new staff and students when needed, submit Position description renewals for staff on an annual basis, submit annual staff performance reviews, and ensure staff compliance with GUMC requirements and protocol

For the clinical trials for which the Director is the primary coordinator, they serve as the main point of contact for patients in the clinical trial and respond to inquiries from any patient within 24 hours. They necessarily maintain regular contact with each patient in their respective trials, in compliance with 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.

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
• 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 independently make 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 submit applications in OnCore/CTMS and the GU Institutional Review Board system
• Ability to maintain a current working knowledge of current ORQA policies and to supervise and advise employees on same
• Ability to demonstrate excellent organizational skills and communication skills, and work independently and collaboratively with investigators and subjects
• Self-direction and attention to detail
• Ability to independently manage several tasks and projects at one time, while still providing consistent oversight and guidance to the employees who they manage
• Capacity and confidence with decisions regarding hiring and terminations decisions and performance management
• Ability to maintain all of the same requirements as a Clinical Trial Coordinator/Manager, including but not limited to: current CITI Group 1 Biomedical, HIPAA, and IATA Training
• Exposure to/experience handling human biological specimens
• Ability independently operate a centrifuge and to process and ship laboratory samples independently
• Experience accessing and reading patient medical records 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 - e.g. , know 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 know 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 .