Source Document Specialist

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.

• 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.

• 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 Clinical Practice (GCP) guidelines, 21 CFR Part 11 compliance, and clinical trial documentation standards.
  • Microsoft Excel, Word, SharePoint, and other digital documentation tools.
• Certified Clinical Research Coordinator (CCRC) – from ACRP (Association of Clinical Research Professionals)
• Certified Clinical Research Professional (CCRP) – from SOCRA (Society of Clinical Research Associates)
• Good Clinical Practice (GCP) Certification – required or obtained upon hire. 

We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. 

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.

Care Access is unable to sponsor work visas at this time.

If you need an accommodation to apply for a role with Care Access, please reach out to: TalentAcquisition@careaccess.com