Sr. Regulatory Protocol Coordinator

111 Michigan Avenue Northwest Washington, DC 20010

Kids Are Our Everything.

Department

10379 Ctr for Cancer Immunology Rsch

Pay Range

$65,124.80 - $

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.

Bachelor's Degree (Required)

Master's Degree (Preferred)

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)

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.

• 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
• 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…