Manager, Clinical Research Operations

I. DEPARTMENT INFORMATION Founded in 1824, the GW School of Medicine and Health Sciences (SMHS) is the 11th oldest medical school in the country and the first in the nation's capital. Since its establishment, the school has been at the forefront of medical education, and has grown to include highly-ranked programs in the health and biomedical sciences. With dozens of top-tier residency programs, SMHS is a competitive and esteemed destination for medical school graduates across the country. This position is a leadership position that supervises clinical research staff assigned and is responsible for the conduct/implementation of clinical trials in the Department of Neurology. This position ensures that our research staff are appropriately trained on the Federal Regulations as well as GW University Policies and Procedures governing research activities so that research is conducted in the most compliant manner. Responsibilities include: Coordinate and supervise Clinical Research Staff. Provide subordinates with project-specific training and have regular meetings with them. Oversee new employee orientation of clinical research staff. Lead development and oversight of departmental/divisional clinical operations for research protocols including recruitment, screening, enrollment, informed consent, any clinical procedures required by the protocol such as physical exams, imaging, specimen collection, survey completion, participant reimbursements and tracking. Collaborate with the Principal Investigators and sponsor to set targets for clinical recruitment and ensuring recording of trial in compliance with project goals. Assist the Principal Investigators in writing and submitting IRB protocols. Assist the Principal Investigators with IND applications to the FDA including preparation of IND applications. Create and implement study-specific clinical monitoring tools and documents. Create and oversee trial budget in collaboration with the Manager of Clinical Research Finance. Take on Clinical trials as needed Work with clinical research coordinators and other staff to prepare informed consent forms, review and prepare informed consent changes for appropriate language. Must have thorough understanding of guidelines in consent language, being able to explain, in detail, what is within the research protocol and its impact on the potential subject. Coordinate, arrange and oversee site visits from sponsors. Gather and examine trial documents. Assure compliance SOPs and local regulations, and CFR, ICH and GCP guidelines. Provide assistance to faculty in preparing grant proposals and help identify funding sources and opportunities for research. Assist with monthly billing/invoicing for funded clinical trials; verifying financial data for accuracy, completeness and conformance with clinical trial study budgets and includes accurate input of budget and payment milestones into tracking systems. In collaboration with the Clinical Research Finance Manager follow monthly tracking of payments and payment issues so that contracts and budgets can be renegotiated if necessary. Assist in monitoring outstanding invoices, tracking collection, reducing accounts receivable balance. Assist GW investigators in resolving research-related billing issues (in collaboration with individuals in the MFA and Hospital). Take on special projects or tasks as required and needed by the Director of the CTO. Perform other related duties as assigned. The omission of specific duties does not preclude the supervisor from assigning duties that are logically related to the position. II. POSITION INFORMATION Campus Location: Foggy Bottom, Washington, D.C. College/School/Department: School of Medicine and Health Sciences (SMHS) Family: Research and Labs Sub-Family: Clinical Research Operations Stream: Management Level: Level 2 Full-Time/Part-Time: Full-Time Hours Per Week: 40 Work Schedule: Monday - Friday 8:00AM - 5:00PM Will this job require the employee to work on site? Yes Employee Onsite Status: On-campus (in person) Telework: (blank) Required Background Check: Criminal History Screening, Education/Degree/Certifications Verification, Social Security Number Trace, and Sex Offender Registry Search Special Instructions to Applicants: Employer will not sponsor for employment Visa status Internal Applicants Only? No Posting Number: R002451 Job Open Date: 08/11/2026 Job Close Date: (blank) Background Screening: Successful Completion of a Background Screening will be required as a condition of hire. Minimum Qualifications Qualified candidates will hold a BA/BS in a related discipline plus 6 years of relevant professional experience or, a BA/BS in a related discipline plus 5 years of relevant professional experience with a certification or, a Master's degree or higher in a relevant area of study plus 4 years of relevant professional experience. Degree must be conferred by the start date of the position. Hiring Range $76,088.27 - $123,763.85 GW Staff Approach to Pay How is pay for new employees determined at GW? Healthcare Benefits medical dental vision life & disability insurance time off & leave retirement savings tuition well-being various voluntary benefits Preferred Qualifications High emotional intelligence Strong analytic skills Superb organizational skills, attention to detail and follow through Collaborative work ethic EEO Statement The university is an Equal Employment Opportunity employer that does not unlawfully discriminate in any of its programs or activities on the basis of race, color, religion, sex, national origin, age, disability, veteran status, sexual orientation, gender identity or expression, or on any other basis prohibited by applicable law. #J-18808-Ljbffr George Washington University