Protocol Coordinator

Position Summary

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.