Clinical Research Source Document Specialist (Source Writer)

Job description:The Source Document Specialist is responsible for developing, standardizing, and maintaining high-quality source documentation used in clinical trials. They will create, edit, and manage study-specific source documents based on trial protocols. This role ensures that source documents align with protocol requirements, regulatory standards, and site workflows to support accurate, complete, and audit-ready data collection.

Responsibilities:

• Source Creation: Develop and design source documents based on study protocols, schedule of assessments, sponsor requirements, and other sponsor provided materials.
• Protocol Translation: Analyze clinical protocols to develop clear, compliant source documents, worksheets, and templates for patient visits.
• Version Control: Maintain and update source document templates for protocol amendments and process changes.
• Quality Control (QC): Ensure all created documents adhere to \(ICH/GCP\) guidelines, FDA regulations, and sponsor requirements.
• EDC Alignment: Structure source documents to align directly with Electronic Data Capture (EDC) systems to ensure high-quality data collection.
• Collaboration: Work with clinical operations, Site Managers, and Investigators to create user-friendly templates.
• Study Start-Up: Support study start-up timelines by creating and delivering source documents within required deadlines.
• Study Management: Support ongoing study activities by continuing to build and refine source throughout the course of a study, from start-up to close-out.
• Task Switching: Ability to manage source for multiple ongoing studies and create source for new studies, each with different disease focus areas, dosing schemas, visit activities, and protocol requirements, while producing quality work for each protocol.

Core Competencies:

• Analytical thinking and problem-solving
• Clear written and verbal communication
• Process improvement mindset
• Cross-functional collaboration
• Time management and deadline adherence
• Microsoft Word Proficiency

Job Type/Work Environment:

Full Time. Office environment.

Example of Impact
A well-designed source document from this role allows a study coordinator to follow a patient visit step-by-step without needing to interpret the protocol in real time—reducing errors, improving data quality, and minimizing queries from monitors and sponsors.

Minimum Qualifications:

• Exceptional attention to detail and organizational skills.
• Experience in clinical research (e.g., CRC, CRA, data management, or regulatory) is required.
• Ability to interpret technical documents and translate them into practical tools.
• Proficiency in Microsoft Office (especially OneDrive, Word, and Excel).

Job Type: Full-time

Pay: $20.00 - $28.00 per hour

Benefits:

• 401(k) matching
• Flexible schedule
• Flexible spending account
• Health insurance
• Paid time off

Education:

• High school or equivalent (Required)

Experience:

• Clinical Trials: 1 year (Preferred)
• Clinical Research: 1 year (Preferred)
• Healthcare : 1 year (Preferred)

Work Location: In person

Salary : $20 - $28