Clinical Trials Manager (Washington)

Clinical Trial Manager

Georgetown University comprises two unique campuses in the nation's capital. With the Hilltop Campus located in the heart of the historic Georgetown neighborhood, and the Capitol Campus, just minutes from the U.S. Capitol and U.S. Supreme Court, Georgetown University offers rigorous academic programs, a global perspective, and unparalleled opportunities to engage with Washington, D.C. Our community is a close-knit group of remarkable individuals driven by intellectual inquiry, a commitment to social justice, and a shared dedication to making a difference in the world.

The Clinical Trial (CT) Manager is responsible for managing and coordinating seven out of approximately 55 ongoing clinical trials...requires refined technical knowledge gained through formal education in a health-related or scientific field, as well as strong organizational, 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 described in the Responsibilities section. At the time of the visit, the CTM is responsible for conducting 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 must maintain a comprehensive functional knowledge of the ancillary departments to be involved in trial visits (e.g., Radiology, CRU, Cardiology) and must be able to communicate and coordinate with such departments effectively. The CTM must be capable of performing his / her job maintaining patient confidentiality at all times, and must adhere to the University requirements for the conduct of clinical research. Therefore, additional job requirements include, but are not limited to : regulatory maintenance, development and adherence of training requirements / materials, 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 for this position will be responsible for coordinating seven studies, which will be conducted at the Georgetown University Hospital Dept. of Neurology. The incumbent will spend five days per week on site for these trials. The CTM will meet project deadline expectations, be proficient multitasker, patient-oriented and have the ability to prioritize tasks.

Work Interactions

As an employee of Georgetown University, the incumbent 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 is required to be the main point of contact for a patient in a clinical trial and must respond to inquiries from any patient within 24 hours. The CTM is instructed and required to maintain regular contact with each patient in their respective trials, because it is 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. In the overall scheme of the Georgetown University Medical Center, this position indirectly and directly supports multiple departments. From a fiscal perspective, the indirect / overhead costs generated by clinical trials support the GUMC operating costs. Without an experienced CTM in this position, we cannot participate in the trials specified in this application, and / or future clinical trials, which would significantly hurt the revenue that these trials generate. This would be detrimental to the ongoing clinical trial operations at our site. 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, the position indirectly supports research-related operations in departments ancillary to Neurology. On a daily basis, the incumbent will report to the Director of Clinical Trials. The CTM is part of a robust team comprised of seven CRC IIs (including the incumbent), three directors of clinical trials, and four student assistants. The CTM is responsible for managing at least seven trials out of the overall portfolio of approximately 55 ongoing trials within our specific department. While the incumbent's primary direct report is to the Director of Clinical Trials, the CTM will also provide project-specific deliverables to others on the team, the PI for each trial, and to the sponsor contact (e.g., the study monitor appointed by the sponsor for each trial). The Director of Clinical Trials rely on timely responses from all CTM / CRC IIs 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 incumbent's portfolio requires ongoing communication with participants currently enrolled in each trial. The incumbent must respond to questions from patients in their portfolio in a timely manner; triage issues as they arise, facilitate communication between the PI / Sub-Is and patients for adverse events and clinical concerns, schedule future visits, send reminders for upcoming visit, ensure that the timing of the visit will work for any PIs / Sub-Is involved, reschedule when necessary, etc.

Requirements and Qualifications

• Bachelor's degree in a health-related or scientific field (e.g., Biology, Nursing, Public Health, Clinical Research, or a related discipline)
• Three years of experience working in a clinical setting that involves direct patient interaction, in a full time, part time, or extensive volunteer experience
• Two year minimum experience will be as a Clinical Trial Coordinator, Clinical Research Assistant, or equivalent position. However, as this is a niche area of expertise, candidates with at least three years' 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)
• Must have experience working with Neurology patients
• Must be able to demonstrate knowledge of their experience working with such patients and possess an understanding of the unique characteristics of these diseases
• Previous experience with regulatory maintenance, preparation, and IRB submission activities
• Must have current CITI Group 1 Biomedical, HIPAA, and IATA Training
• Must have previous exposure to / experience handling human biological specimens; must be able to operate a centrifuge and be capable of processing and shipping laboratory samples independently
• Must have phlebotomy experience
• Must have previous experience accessing and reading patient medical records and must have a general working knowledge of medical care / medical operations and regulations
• Must have clinical experience 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 is able 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)
• Highly detail oriented, organized
• Able to follow directions
• Able to work respectfully in a team
• Must be able to demonstrate moral and ethical responsibility and maintain professionalism at all times
• Must have excellent communication skills with respect to external communication (patients, sponsors, sponsor affiliates) and internal communication (manager, team members, PI, Sub-Is, ancillary department). Specifically, written communication must be clear, detailed, and free of errors
• Verbal communication must be clear, relevant, and respectful at all times

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.

Pay Range : The projected salary or hourly pay range for this position which represents the full range of anticipated compensation is : $47,586.00 - $87,558.13 Compensation is determined by a number of factors including, but not limited to, the candidate's individual qualifications, experience, education, skills, and certifications, as well as the University's business needs and external factors.

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.

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