Source Document Specialist
Careaccess · USA Remote · Posted Jul 2, 2026
Apply on company site Track it in JobSkout
About Care Access
Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow.
With programs like Future of Medicine , which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers , which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all.
To learn more about Care Access, visit www.CareAccess.com .
How This Role Makes a Difference
The Source Document Specialist is responsible for ensuring accurate, compliant, and efficient clinical trial documentation. This role translates complex study protocols into clear, structured source documents that support high‑quality data collection and regulatory compliance. Serving as a key partner to site staff and study teams, the Specialist manages version control, improves documentation workflows, and safeguards data integrity.
How You'll Make An Impact
Review and validate source documents (eSource and paper) to ensure completeness, accuracy, and alignment with study protocols, while ensuring compliance with GCP, 21 CFR Part 11, and internal SOPs.
Review protocol amendments and other study changes to assess impact on source documents, communicate required updates to the source team, and submit revisions as needed.
Coordinating with source creators, site staff and internal teams for feedback and approval.
Manage daily communication with site staff, study teams, and internal departments regarding source document updates, requests, and training support.
Support quarterly initiatives, including process improvements, training development, and workflow optimizations for source documentation
Participate in cross-functional meetings to provide input on study start-up timelines, protocol changes, and documentation impact analysis.
Conduct internal audits and quality checks to ensure adherence to documentation standards and regulatory compliance
Provide feedback to help update standardized templates and checklists to improve the efficiency of source document review.
The Expertise Required
The Source Document Specialist must demonstrate a strong understanding of clinical trial protocols, GCP, and applicable regulatory requirements, including 21 CFR Part 11, to ensure compliant source documentation. Prior experience in clinical trials—particularly in a Clinical Research Coordinator (CRC) or Quality Assurance (QA) or similar role—is preferred and provides valuable insight into study workflows and data collection needs.
The role requires proficiency in Microsoft Excel, Word, Outlook, Teams, and SharePoint, along with the ability and willingness to work within eSource platforms such as CRIO. Strong attention to detail is essential to identify discrepancies, manage version control, and ensure accuracy and traceability of source documentation.
Successful candidates will demonstrate excellent organizational skills, the ability to prioritize tasks in a fast‑paced environment, and effective communication skills for collaborating with site staff, study teams, and regulatory stakeholders. Strong analytical and problem-solving skills, with the ability to interpret complex study requirements are critical to success in this role. A solution‑oriented mindset and the ability to assess and improve documentation workflows are equally important. The position requires comfort working both independently and as part of a global team, managing multiple systems, and adapting to evolving research and technology needs.
Fluency in English (reading, writing, and speaking) is required to communicate effectively with the global Source team and to review English‑language protocols, manuals, and regulatory documentation.
Certifications/Licenses, Education, and Experience
Minimum Education:
Bachelor’s degree in a health-related field (e.g., Life Sciences, Nursing, Public Health, or a related discipline) preferred. Equivalent work experience in clinical research may be considered.
Minimum Experience:
Minimum of 2 years of experience in clinical research, with preferred experience as a Clinical Research Coordinator (CRC) or in a role involving source documentation, study execution, or regulatory compliance.
Strong knowledge of clinical trial operations, including protocol interpretation, source creation, and site workflow processes.
Experience working with Good Clinica…