Manager, Clinical Trials

Please see Special Instructions for more details. Employer will not sponsor for employment Visa status I. DEPARTMENT INFORMATION Job Description Summary: The George Washington University is actively involved in a wide range of cancer-related activities, from basic science and clinical research to outstanding patient care and health policy. As a means of maintaining its commitment to expanding its efforts in the fight against cancer, GW leverages the School of Medicine and Health Sciences, the GW Hospital, and the Milken Institute School of Public Health to refocus and re-energize the university’s efforts in cancer research and patient care. For cancer research, these four organizational pillars have established a firm goal of obtaining NCI designation as a cancer center within 10 years, and for cancer care, they seek to position GW and its cancer center as the providers of choice in the Washington, D.C. area. To achieve these goals, GW leadership has embarked on the creation of the GW Cancer Center ( GWCC ), which will incorporate all existing cancer-related activities and serve as the platform for future development. The GW Cancer Center is searching for a full-time Manager, Clinical Trials within the GW Cancer Center Clinical Trials Office, reporting to the Faculty Head of the Clinical Trials Office. This position will serve as Manager for the GW Cancer Center Clinical Trial Office ( CTO ), which includes the operational teams and the Protocol Review and Monitoring Systems ( PRMS ) of the Cancer Center. The duties include, but are not limited to: providing oversight of clinical research activities, ensuring compliance with established federal, state, local and institutional guidelines governing the conduct of clinical research; implementing processes and procedures to improve compliance and the programmatic and fiscal integrity of the clinical research activities; effectively communicating with the GW Cancer Center Director and Associate Center Directors, investigators, research staff, and representatives of study sponsors to facilitate the research activities; coordinating the work and responsibilities of research staff; analyzing study protocols, contracts, and budgets; coordinating, evaluating, and following patient participation in clinical trials; developing strategies for patient recruitment, compliance, and maintenance; serving as liaison for internal and external vendors; conducting presentations to sponsors and organizations; participating in meetings and task forces pertinent to conducting oncology research. Other duties also include coordinating with the sponsoring pharmaceutical and biotechnology companies in: a) implementation of clinical trials; b) safety data collection and reporting; c) supervision of trial-related sample collection and shipping; and d) assisting the Clinical Trials Office to create budgets for the activities performed in the GW Cancer Center. This position is also responsible for promoting a customer-friendly environment and providing superior service to our patients, students, faculty, and employees. Principal Duties and Responsibilities: Responsible for appropriate staffing and skills to adequately administer the CTO core functions. Supervise the training/development and performance management for Research Study Assistants, Research Project Coordinators, and Clinical Research Coordinators (direct and indirect reports). Responsible for the hiring of new staff. Develop and implement strategies to continuously improve employee engagement. Collaborate closely with the Associate Director for Clinical Investigations, chair(s) of the protocol review and monitoring systems ( PRMS ), and committee(s) to assure the ultimate success of clinical research programs. Keep abreast of current state-of-the-art developments relating to clinical trials and provide education to clinical staff and other team members. Participate in conferences, scientific meetings, and writing of abstracts. Leadership Provide operational leadership and effective management for the GW Cancer Center Clinical Trials Office ( CTO ), including community–based partners, consortia members, and outreach clinics. Responsible for coordinating all aspects of clinical research operations at the Cancer Center to ensure that high-quality and ethical clinical research is conducted within an environment that facilitates clinical research and that will enhance the scientific reputation of the Cancer Center both nationally and internationally Manage the expansion of clinical research activities to satellite sites and affiliates Oversee the structure and processes of the PRMS , including Scientific review and DSMP functions Assure compliance with the GCP , human subjects’ protection, and all regulatory agencies Build the appropriate infrastructure to support clinical trial-related activities. Clinical Trials Program Oversight Develop, implement, and update SOPs to ensure consistent, safe, and efficient management of clinical trials and the subjects enrolled. Provide oversight over clinical research informatics matters related to CTO operations and clinical research conduct in collaboration with the relevant Cancer Center and institutional managers. Ensure quality, timely, accurate data submission. Develop quality control mechanisms and systems for the management of data. Generate protocol status reports for key stakeholders including Principal Investigators, leadership, clinical teams, institutional review board, etc. Provide oversight for monthly reports about accrual, monitoring, and audit visits. Provide oversight and guidance for monthly reports of income from industry-sponsored trials as well as grants. Accountable for accuracy of trial information in all trial databases and tracking systems. Lead QA functions for the clinical research operations; participate in routine audits for data quality, regulatory compliance, patient safety issues related to clinical trials, etc. Actively work to address quality improvement opportunities. Incorporate a patient-centered approach that consciously includes the patient and family’s perspective and focuses on needs as they define them. Performs 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. Minimum Qualifications: Qualified candidates will hold a BA/BS in a related discipline plus 6 years of relevant professional experience. Degree must be conferred by the start date of the position. Preferred Qualifications: Demonstrated comprehensive skills and training in clinical research and business administration, including financial management, personnel administration, program planning, development, and implementation, are desired. Working knowledge of FDA regulations governing clinical research, Good Clinical Practice, and OHRP regulations is a plus. Previous supervisory experience is preferred. Excellent interpersonal and verbal/written communication skills. RN or MS/ MPH preferred, with two years of management and three years of oncology clinical research experience desired. Ability to utilize clinical research databases and learn/train is a plus. Previous experience coordinating and managing oncology clinical research programs, especially in an academic medical center setting, is preferred. Proficiency in Excel and PowerPoint is a plus. GW offers a comprehensive benefit package that includes medical, dental, vision, life & disability insurance, time off & leave, retirement savings, tuition, well-being and various voluntary benefits. For program details and eligibility, please visit II. POSITION INFORMATION Campus Location: Campus Location: Foggy Bottom, Washington, D.C. College/School/Department: College/School/Department: School of Medicine and Health Sciences (SMHS) Family Family Research and Labs Sub-Family Sub-Family Centers/Institutes Stream Stream Management Level Level Level 2 Full-Time/Part-Time: Full-Time/Part-Time: Full-Time Hours Per Week: Hours Per Week: 40 Work Schedule: Work Schedule: M-F, 8:30 a.m. - 5:00 p.m. Will this job require the employee to work on site? Will this job require the employee to work on site? Yes Employee Onsite Status Employee Onsite Status Hybrid Telework: Telework: Yes Required Background Check 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? Internal Applicants Only? No 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 The George Washington University