Protocol Coordinator

The Protocol Coordinator shall provide administrative and technical support for VA CIRB operations, including protocol review processing, meeting coordination, documentation management, and post-approval support activities. Key Responsibilities·        Manage new study submissions and post-approval activities, including amendments and continuing reviews.·        Perform administrative and technical reviews of study documentation for completeness and compliance.·        Identify deficiencies and coordinate corrective actions with study teams.·        Coordinate protocol reviews among investigators, study teams, and IRB members.·        Maintain accurate protocol documentation and version control records.·        Draft interim and final IRB correspondence and approval letters.·        Support development and management of IRB meeting agendas.·        Attend IRB meetings and prepare meeting notes and minutes.·        Finalize meeting documentation in accordance with VA and federal requirements.·        Revise and maintain SOPs, forms, templates, reports, and checklists.·        Conduct annual protocol file audits and support oversight inspections/site visits.·        Provide administrative support for IRB operations and respond to inquiries received through the VA Central IRB toll-free line.·        Utilize approved IRB systems and platforms to manage protocol documentation and workflow activities. Minimum Qualifications·        Minimum 3 years of IRB or human subjects research administration experience. ·        Strong written and oral communication skills. ·        Experience with protocol documentation and regulatory processes preferred. Security Requirements·        Must successfully complete VA-required background investigation and security requirements.