Job Description

The Clinical Research Protocol Coordinator provides clinical trials regulatory support for the Center for Cancer and Immunology Research department, including specific groups as assigned. The Clinical Research Protocol Coordinator will work with Principal Investigators (PIs) on protocol writing and editing (including format and addition of administrative sections); prepare amendments, continuing reviews, problem reports, including all necessary forms. Work with research staff on the development of clinical research and clinical trial protocols, informed consent documents, and other regulatory or study-related documents. Review and ensure that protocols and informed consents meet regulatory requirements and are written in a format compatible with the guidelines. Work with research teams to prepare submissions to the appropriate regulatory bodies (e.g., Institutional Review Board, Data and Safety Monitoring Entity, etc.). Collaborate with staff on IND and IDE safety, clinical study reports, and other regulatory correspondences, including initial submissions, information requests, amendments, and annual reports. Manage, track, and coordinate regulatory activities for all assigned protocols, under the guidance of the PIs, from conception/development through the protocol lifecycle to study closures. Help CRCs maintain all regulatory trial documentation, including a complete and up-to-date Regulatory Binder for each trial, documentation of investigator qualifications, trial logs, and safety reports. Work with PI and research staff on coordinating and scheduling monitoring and auditing visits by regulatory bodies as needed. Minimum Education Bachelor's Degree in health sciences, clinical research, or applicable discipline. Knowledge of biological or health sciences gained through advanced education (e.g., M.A., M.S., M.P.H., M.S.N., N.P., P.A., Ph.D.) or equivalent training is preferred. (Required) Master's Degree (Preferred) Minimum Work Experience At least 4 years of applicable work experience (e.g., research, clinical, interaction with study population, program coordination). Requires at least three years of experience implementing and/or overseeing Phase I through Phase III trials. Experience in health-related, clinical research, or clinical care, with broad knowledge of procedures and policies related to clinical trials, is required. Prior experience with investigator-initiated or pharma-sponsored clinical trials is required. Required Skills/Knowledge Knowledge of clinical research; familiarity with databases, data collection, and analysis; ability to manage multiple responsibilities with attention to detail; effective interpersonal skills; proficiency in MS Office Suite, especially Excel; advanced database management skills; familiarity with electronic health records; quality improvement experience; excellent communication skills. Required Licenses and Certifications Internal candidates should possess one of the following: CCRP, CCRC, CCRA, or CHRC. External candidates must obtain an appropriate research certification within one year of hire. Functional Accountabilities Responsible Conduct of Research Adhere to standards for responsible conduct of research. Maintain current documentation of all certifications and training. Follow institutional SOPs, GCP, ICH, FDA, and OHRP regulations and guidance. Protocol and Regulatory Development Assist with protocol design, study implementation, IND submissions, and IRB submissions. Ensure compliance with regulatory requirements for protocols, consent forms, investigator brochures, and data collection plans. Regulatory Filing and Reporting Prepare regulatory submissions and support IND preparations. Ensure regulatory integrity of protocols and submissions to IRB and sponsor audits. Program Coordination Coordinate with research staff and regulatory entities; ensure document consistency across offices. Quality Assurance Prepare protocol documents and regulatory forms for complex research projects. Analysis Analyze performance metrics and outcome data; respond to customer needs. Teamwork/Communication Collaborate respectfully; share ideas; communicate effectively. Performance Improvement/Problem-solving Contribute to a positive environment; demonstrate flexibility; identify process improvements; exercise sound judgment. Cost Management/Financial Responsibility Use resources efficiently; seek cost-effective solutions. Safety Promote safety; verify information; communicate clearly; act to resolve uncertainties; prioritize safety for all. Additional Details Primary Location: District of Columbia - Washington Work Location: CN Hospital (Main Campus) Job Type: Research, Full-Time, Day shift, 9:00-5:30 PM Organization: Ctr Cancer & Immunology Rsrch Position Status: Regular #J-18808-Ljbffr Children's National Hospital

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