Senior Regulatory & Protocol Lead – Clinical Trials

Children's National Hospital; Washington (District of Columbia); On-site; USD 65,000 - 109,000; Full time

Benefits offered by this job

Health coverage

Generous paid time off

401(k) plan

Job summary

Children’s National Hospital in Washington, DC, seeks a Senior Regulatory/Protocol Coordinator to prepare and submit regulatory documents for investigator-initiated and multi-site trials, and to manage continuing reviews and amendments. You will ensure compliance with FDA, IRB, and GCP standards while collaborating with PIs and research teams to maintain high-quality trial documentation.

The role requires a Bachelor's (Master's preferred) and at least 3 years of trial oversight experience.

Qualifications

• Bachelor's degree required; Master's preferred.
• Minimum 3 years' experience in Phase I–III trials.
• Strong knowledge of clinical research regulations and SOPs.
• Proficient with MS Office, especially Excel.
• Ability to manage multiple regulatory projects with attention to detail.

Responsibilities

• Prepare and submit regulatory documentation to IRB, FDA, and applicable committees.
• Develop and review study documents including protocol and consent forms.
• Process new submissions, continuations, amendments, and adverse event reports.
• Coordinate with PIs and teams to address stipulations and approvals.
• QC regulatory documents and maintain up-to-date trial records.
• Educate staff on protocol development, regulatory requirements, and submission processes.

Skills

Clinical research knowledge

MS Excel proficiency

Attention to detail

Interpersonal communication

Regulatory document preparation

Education

Bachelor's Degree

Master's Degree

Tools

IRB submissions

FDA IND knowledge

Electronic health records

Job description

Children’s National Hospital in Washington, DC, seeks a Senior Regulatory/Protocol Coordinator to prepare and submit regulatory documents for investigator-initiated and multi-site trials, and to manage continuing reviews and amendments. You will ensure compliance with FDA, IRB, and GCP standards while collaborating with PIs and research teams to maintain high-quality trial documentation.

The role requires a Bachelor's (Master's preferred) and at least 3 years of trial oversight experience.