Senior Regulatory & Protocol Specialist — Investigator Trials

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

Benefits offered by this job

Health coverage

Paid time off

401(k) plan

Life insurance

Tuition assistance

Job summary

Children's National Medical Center in Washington, DC is seeking a Senior Regulatory/Protocol Coordinator to prepare and submit moderately complex protocols and amendments to IRB, FDA and other regulatory bodies, and to maintain comprehensive regulatory documentation for investigator-initiated trials.

Reporting to the Clinical Research Program Director, the role requires a Bachelor's degree (Master's preferred) and 3+ years of trial oversight experience; strong MS Office and database skills; and

Qualifications

• Knowledge in clinical research and regulatory practices.
• Experience with FDA, IRB and GCP guidelines.
• Strong communication and documentation skills.

Responsibilities

• Prepare regulatory submissions and maintain trial documentation.
• Coordinate with IRB, FDA and other committees for reviews and amendments.
• Manage protocol start-up, amendments, and reporting requirements.
• Ensure compliance with HIPAA, GCP and regulatory standards.
• Generate reports and maintain files for audits and inspections.
• Educate research staff on regulatory processes and SOPs.
• Maintain and update clinical trial status on registries as required.
• Support IND submissions and regulatory communications with FDA.

Skills

Clinical research knowledge

Data collection & analysis

Database familiarity

Multitasking ability

Interpersonal skills

Microsoft Excel

Database management

Electronic health records

Quality improvement

Oral & written communication

Education

Bachelor's Degree

Master's Degree

Tools

Microsoft Excel

MS Office Suite

Job description

Children's National Medical Center in Washington, DC is seeking a Senior Regulatory/Protocol Coordinator to prepare and submit moderately complex protocols and amendments to IRB, FDA and other regulatory bodies, and to maintain comprehensive regulatory documentation for investigator-initiated trials.

Reporting to the Clinical Research Program Director, the role requires a Bachelor's degree (Master's preferred) and 3+ years of trial oversight experience; strong MS Office and database skills; and