Senior Regulatory Protocol Lead — Clinical Trials

10100 Children's Hospital; Washington (District of Columbia); On-site; USD 65,000 - 109,000; Full time

Benefits offered by this job

Comprehensive health coverage

Generous paid time off

401(k) plan

Life, AD&D, and long-term disability

Tuition assistance

Commuter benefits

Job summary

Children's National Hospital in Washington, DC is seeking a Senior Regulatory/Protocol Coordinator to prepare and submit regulatory documents for investigator-initiated trials and multi-site studies. You will oversee IRB submissions, FDA interactions, and protocol development while ensuring compliance with GCP, FDA, and local regulations.

The role requires a Bachelor's degree (Master's preferred) and 3+ years of experience in conducting or overseeing phase I–III trials, with strong MS Office and

Qualifications

• Bachelor’s degree in a relevant field is required.
• Master’s degree is preferred.
• Experience with clinical trials from Phase I–III desired.
• Strong knowledge of regulatory processes and documentation.

Responsibilities

• Prepare and submit regulatory documents to IRB, FDA, and applicable committees.
• Develop investigator-initiated protocols and regulatory submissions, including INDs.
• Review and QC documents for compliance with regulatory requirements.
• Coordinate with PIs, research staff, and external regulatory bodies to address stipulations.
• Maintain and organize regulatory files and generate compliance reports.

Skills

Clinical research knowledge

Data collection & analysis

Multitasking

Interpersonal communication

MS Office / Excel

Database management

Familiarity with EHR

Quality improvement

Oral & written communication

Education

Bachelor’s degree

Master’s degree (preferred)

Job description

Children's National Hospital in Washington, DC is seeking a Senior Regulatory/Protocol Coordinator to prepare and submit regulatory documents for investigator-initiated trials and multi-site studies. You will oversee IRB submissions, FDA interactions, and protocol development while ensuring compliance with GCP, FDA, and local regulations.

The role requires a Bachelor's degree (Master's preferred) and 3+ years of experience in conducting or overseeing phase I–III trials, with strong MS Office and