Regulatory Affairs Coordinator

111 Michigan Avenue Northwest Washington, DC 20010 Kids Are Our Everything. Department 10379 Ctr for Cancer Immunology Rsch Pay Range $65,124.80 - $108,555.20 Reporting to Clinical Research Program Director, the Senior Regulatory/Protocol Coordinator will prepare and submit moderately complex protocols and supporting documentation to regulatory bodies and research committees. In this role, the coordinator will also submit the continuing review and amendments to regulatory bodies and address a broad range of stipulations that may arise. In addition, he/she will generate reports and maintains files and documentation for compliance with regulatory requirements (federal and local agencies, including the Food and Drug Administration and Local Institutional Review Board) for investigator-initiated trials and investigator-initiated multi-site trials. Minimum Education Bachelor's Degree (Required) Master's Degree (Preferred) Minimum Work Experience 3 years experience implementing and/or overseeing Phase I through Phase III trials to acquire the skills necessary to audit human subject's research. (Required) Required Skills/Knowledge Knowledge in clinical research; familiarity with databases, data collection and analysis, able to manage multiple responsibilities and activities with close attention to detail. Effective interpersonal skills and ability to communicate with a diverse group of individuals. Must have demonstrable proficiency in MS Office Suite - particularly Microsoft Excel. Must also have advanced database management skills, familiarity with electronic health records, quality improvement experience and excellent oral and written communication skills. Functional Accountabilities Responsible Conduct of Research Demonstrates consistent adherence to the standards for responsible conduct of research. Complies with and maintains current documentation of all job-related certifications and training. Maintains and shares intimate knowledge of institutional SOPs, GCP, ICH, FDA and OHRP regulations and guidance Protocol and Regulatory Development Work with PIs and the research team on the design, plan, production and revision of study documents, including applying clinical and regulatory knowledge to the review of protocol and informed consent documents. Prepare and process all regulatory documentation through the IRB, FDA and all applicable regulatory review committees- including new submissions, continuing reviews, amendments, adverse events, and reportable events. Facilitate the development of investigator-initiated research protocols, the development and submission of FDA IND applications and annual reports, and development/maintenance of study specific case report forms and source document tools, as well as, to facilitate direct regulatory/compliance guidance and oversight of investigator initiated trials and investigator-initiated multi-site trials. Review and quality control (QC) of nonclinical and clinical documents for compliance with regulatory requirements, such as clinical protocols, informed consent forms, investigator documentation, clinical and nonclinical study reports. Work with research staff to navigate requirements for protocol approval and continued conduct: complete submissions to approving bodies (e.g., scientific review, IRB and radiation safety), coordinate with PIs and the research team to ensure stipulations are addressed appropriately and on-time; track the required approvals necessary to initiate and continue research. Orchestrate meetings with Principal Investigators (PIs) and other key research staff to manage protocol start-up and continuation logistics. Work with the Institutional Review Board (IRB) to keep abreast of new guidance related to protocol and informed consent submissions for both initial reviews and amendments, and to share relevant information with Protocol Navigation (PN) and research team members. Educate research staff regarding relevant aspects of regulatory process including requirements of protocol development, conduct of research trials, regulatory change, IRB and FDA submission requirements, radiation safety requirements, ethics clearances, and technology transfer. Completes forms and generates reports from multiple data sources to comply with the assigned protocols for the study and/or clinical trial. Maintains research files and may audit documentation pertaining to regulatory requirements for clinical trials. Partners with research staff and investigators to ensure that all regulatory documents for the assigned research studies are up to date. Represents the unit in cross functional meetings and provides updates on the status of assigned regulatory submissions. Supports the unit in internal and external auditing of regulatory documents. Identifies quality and performance improvement opportunities to support efficient workflows. Maintains strict patient confidentiality according to HIPAA regulations and follows guidance according to applicable law, research practices using Good Clinical Practice (GCP) guidelines. Supports the unit with the submission of Investigational New Drug (IND) Applications to the Food and Drug Administration (FDA) for investigator-initiated clinical trials. Acts as primary contact for all FDA communication, including submission of serious adverse events, amendments, annual reports, and other submissions as required. Updates and maintains records of clinical trial status on clinicaltrials.gov website as mandated by FDA and National Institutes of Health (NIH). Analyzes moderate to complex clinical research data related to oncology, immunology, microbiology, etc; Assists in interpreting clinical research data used in scientific publication. Create and modify department SOPs that reflect best practices and comply with applicable legal requirements. Perform literature searches, attend meetings, etc. as needed to support regulatory document preparation, regulatory intelligence, and regulatory strategy, and to stay current with applicable therapeutic areas of clients. Program Coordination Collaborate with clinical research scientists, Principal Investigators, Research Coordinators, and safety, regulatory, and monitoring entities. Coordinate with other offices (e.g., Office of Human Subjects Research Protections,) to integrate and ensure consistency of new/revised documents with policies. Prepares plans and recommendations for any identified necessary changes. Quality Assurance Responsible for preparing protocol documents and required regulatory forms in order to obtain institutional and regulatory agency approval for the conduct of the more complex clinical research projects. Analysis Analyze and prepare performance measures and outcome metrics. Benefits That Support YouComprehensive health coverage, including medical, prescription, infertility, and transgender health services. Generous paid time off, including vacation accrual fromday one, sick leave, holidays, and a personal day. Financial wellness support, including a 401(k) plan and healthcare and dependent care spending accounts. Employer-paid life, AD&D, and long-term disability coverage, with optional supplemental plans. Additional perks, including tuition assistance, fitness resources, employee assistance, commuter benefits, and more.