Source Document Specialist
Please mention DailyRemote when applying
AI Summary
The specialist is responsible for creating, maintaining, and executing source documents for research studies in accordance with protocols and regulatory standards. They also provide guidance and training to site staff on best practices for source documentation.
Position Summary:
The Source Document Specialist creates, maintains, and executes source documents within the company in accordance with the protocol and contracted scope of work.
Key Responsibilities:
- Creates source documents for all visits related to upcoming research studies.
- Updates source documents for current or upcoming research studies as needed due to protocol amendments, sponsor/CRO requirements, site staff requests, etc.
- Develops and updates company source document templates.
- Maintains organized and up-to-date records of source documents within the appropriate platforms.
- Ensures accuracy, completeness, and compliance of source documents with the associated protocols, regulatory standards, and internal SOPs.
- Provides guidance and support to site staff regarding source documentation, including training on best practices and regulatory standards as needed.
- Reviews source documents created by staff, comparing requirements of the protocol and other resources to the created source.
- May perform other job-related duties as requested or required.
Skills/Abilities:
- Well-versed in the conduct of clinical trials.
- Subject matter expert of ICH/GCP, regulatory requirements, and FDA and HIPAA policies and practices.
Education/Experience:
- Bachelor's degree in a related field or relevant experience required.
- 2+ years in a source documentation role required.
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