Clinical Research Regulatory & Source Document Specialist

Job Description

Job Description

We are seeking a detail-oriented Clinical Research Regulatory & Source Document Specialist to support our growing clinical research team. This position is responsible for creating and maintaining source documents, reviewing protocol amendments, updating study materials, and ensuring research documentation remains accurate, organized, and compliant with sponsor and regulatory requirements.

The ideal candidate is highly organized, proactive, and experienced in clinical research documentation and protocol management.

Responsibilities

• Create, update, and maintain study source documents for clinical trials
• Review protocol amendments and identify required study changes
• Update source packets, visit worksheets, logs, and study tools following protocol revisions
• Ensure all study documents remain compliant with sponsor, GCP, and site requirements
• Communicate protocol and amendment changes to research staff as needed
• Assist with study startup and ongoing document preparation
• Support quality control efforts and audit readiness
• Maintain accurate filing and version control of study documentation

Qualifications

• Clinical research experience preferred
• Experience reviewing protocols and amendments strongly preferred
• Knowledge of GCP, FDA regulations, and research documentation standards
• Strong attention to detail and organizational skills
• Ability to manage multiple studies and deadlines simultaneously
• Proficient in Microsoft Office and electronic documentation systems
• Medical terminology knowledge preferred
• CRC, regulatory, or research coordinator experience is a plus

Preferred Experience

• Source document creation
• Regulatory coordination
• Protocol review and implementation
• Research quality assurance or quality control
• Sponsor and CRO communication