Summary:
The Source Document Specialist is responsible for developing, reviewing, and maintaining accurate, protocol-specific source documents used in research studies with Clinical Research Coordinator and Investigator approval. This position works closely with Clinical Research Coordinators, investigators, regulatory personnel, and other members of the clinical operations team to ensure source documentation supports protocol requirements, Good Clinical Practice standards, data integrity, and ensure source accuracy to support accurate data entry into electronic case report forms.
Key Duties:
- Review clinical trial protocols, schedules of assessments, laboratory manuals, pharmacy manuals, informed consent forms, EDC guidelines and other study-related materials.
- Develop comprehensive, visit-specific source documents that accurately reflect protocol requirements.
- Create screening, enrollment, treatment, follow-up, and unscheduled visit source template with Clinical Research Coordinator oversight.
- Incorporate required clinical assessments, procedures, laboratory testing, questionnaires, medication administration, and safety evaluations.
- Ensure source documents support complete and accurate data collection for electronic or paper case report forms.
- Maintain source document version control by ensuring all documents are current, accurately labeled, appropriately approved, and properly archived. Track revisions and implementation dates, remove obsolete versions from active use, and ensure updated documents are distributed to the appropriate study personnel in accordance with regulatory requirements and organizational procedures.
- Include appropriate documentation fields for inclusion and exclusion criteria, medical history, adverse events, concomitant medications, protocol deviations, and investigator assessments.
- Revise source documents following protocol amendments, sponsor updates, monitor feedback, or changes to study procedures.
- Perform quality-control reviews to confirm accuracy, consistency, completeness, and alignment with the current approved protocol.
- Maintain version control and ensure outdated source documents are removed from active use.
- Collaborate with Clinical Research Coordinators and investigators to ensure documents are practical and appropriate for site workflows.
- Assist with the standardization of source document templates across studies and research locations.
- Support audit and inspection readiness by ensuring documentation practices meet regulatory and organizational requirements.
- Protect patient confidentiality and comply with applicable privacy and information-security requirements.
- Participate in study start-up meetings and provide source-document support throughout the life cycle of each clinical trial.
- Perform other clinical documentation and quality-assurance duties as assigned. Other duties as assigned
Knowledge, Skills and Abilities:
- Exceptional attention to detail and accuracy.
- Strong understanding of clinical research terminology and study-site operations.
- Ability to identify inconsistencies, missing requirements, and documentation risks
- Strong analytical and problem-solving skills
- Ability to work independently while collaborating effectively with cross-functional teams.
- Excellent time management and prioritization skills.
- Ability to maintain confidentiality and handle sensitive patient and study information.
- Commitment to regulatory compliance, data integrity, and continuous quality improvement.
Pay: $30.00 - $35.00 per hour
Application Question(s):
- Please describe your experience creating clinical research source documents. Include how you have created from study protocols.
- This is a part-time, contract, hybrid position with the majority of work performed remotely. While the schedule offers flexibility, this role requires meeting established deadlines for the creation and delivery of source documents. Are you comfortable working independently and consistently meeting project deadlines?
Experience:
- Clinical research: 2 years (Required)
Work Location: Hybrid remote in Long Beach, CA 90815
