Senior Clinical Protocol Coordinator

Position Title: Clinical Protocol Specialist
Location: Bethesda MD (OnSite)
Institution: National Institute of Dental and Craniofacial Research (NIDCR)
Weekly Hours: FullTime (3040 hours per week)

We are seeking a dedicated Clinical Protocol Specialist to join the Office of the Clinical Director (OCD) at the National Institute of Dental and Craniofacial Research (NIDCR). In this role you will provide comprehensive support for clinical research projects ensuring compliance with regulatory bodies and assisting in the execution of clinical trials. You will be responsible for managing and organizing clinical trial documents coordinating submissions and communicating with regulatory authorities such as the IRB and FDA. This is a great opportunity for someone with experience in clinical research and regulatory compliance.

• Assist researchers in developing and maintaining trial documents including study protocols safety reports amendments and audits.
• Support clinical trial processes from protocol development through to study closure.
• Coordinate with the IRB and NIH Clinical Center for protocol approval and submission of regulatory documentation.
• Manage clinical data and maintain study databases using systems such as CTMS and REDCap.
• Track adverse events monitor protocol submissions and ensure compliance with SOPs and regulatory guidelines.
• Liaise with regulatory bodies (FDA NIH) and pharmaceutical companies for protocol submissions audits and quality assurance activities.
• Educate and train research staff on regulatory processes including protocol submission and safety requirements.

• Education: Masters degree in Pharmacy Pharmaceutical Sciences or a related field.
• Certifications: GMP Certified.
• Experience: Prior experience in clinical trial work especially in Phase I or II trials and experience working with electronic medical records and clinical data systems.
• Familiarity with regulatory compliance protocol development and data integrity.

• Experience with protocol review regulatory submissions and protocol amendments.
• Knowledge of Clinical Trial Management Systems (CTMS) and REDCap.
• Proficiency in Microsoft Office CAPA and NDA filing.
• Strong organizational skills and attention to detail particularly in managing multiple clinical protocols.
• Ability to liaise effectively with regulatory authorities and clinical trial sites.
• Experience with SOP development and quality assurance in clinical research settings.

1. Implementation of Clinical Trial Site Action Plans
2. Liaising with Regulatory Authorities
3. Coordinating Project Meetings
4. Protocol Writing and Revision
5. Regulatory Compliance and IRB Submissions