Join the National Institutes of Health as a Clinical Trials Program Coordinator and help ensure the quality, safety, and integrity of clinical research programs. We are seeking an experienced professional with expertise in clinical trial design and methodology, quality assurance and control, data and safety monitoring, and federal policies and guidance governing research involving human subjects. Develop and implement guidelines, standards, project management plans, and study-monitoring plans to ensure the quality and regulatory compliance of NIMH-sponsored clinical trials. Plan, coordinate, and conduct routine and for-cause, risk-based monitoring and audits of clinical research studies, coordinating centers, and clinical sites. Review clinical protocols, informed-consent documents, study forms, safety reports, and audit findings to ensure compliance with federal regulations, NIH requirements, and Good Clinical Practice. Advise staff, principal investigators, and study personnel on regulatory, clinical, and administrative matters; develop and communicate corrective action plans to resolve compliance issues. Develop and refine systems and informatics tools to monitor clinical-trial progress, risk, quality assurance, data integrity, and participant safety.

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