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 neededWork 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 ng able to explain, t 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 cking 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.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.Preferred Qualifications:High emotional intelligenceStrong analytic skillsSuperb organizational skills, attention to detail and follow throughCollaborative work ethicGW 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 https://hr.gwu.edu/benefits-programs.Hiring Range$76,088.27 - $123,763.85II. POSITION INFORMATIONCampus Location:Foggy Bottom, Washington, D.C.Full-Time/Part-Time:Full-TimeHours Per Week:40Work Schedule:Monday - Friday 8:00AM - 5:00PMWill this job require the employee to work on site?YesEmployee Onsite StatusOn-campus (in person)Special Instructions to Applicants:Employer will not sponsor for employment Visa statusRequired Background CheckCriminal History Screening, Education/Degree/Certifications Verification, Social Security Number Trace, and Sex Offender Registry Search
4 days ago