Source Document Specialist

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. This position supports global clinical research operations, including collaboration with Brazil‑based sites and international teams, and requires regular engagement with global stakeholders and English‑language clinical documentation.

How You'll Make An Impact

• Prepare and develop accurate source documents (eSource and paper) based on clinical trial protocols, ensuring compliance with GCP, 21 CFR Part 11, and internal SOPs.
• Review and validate source documents to ensure completeness, accuracy, and alignment with study protocols, coordinating with site staff and internal teams for feedback and approval.
• Maintain version control, track document updates, and implement protocol amendments efficiently while ensuring compliance with regulatory requirements.
• Manage daily communication with site staff, study teams, and internal departments regarding source document updates, requests, and training support.
• Organize, file, distribute, and archive source documents systematically for each clinical trial, ensuring proper documentation and accessibility.
• 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.
• Develop and update standardized templates and checklists to improve the efficiency of source document creation.

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 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. A solution‑oriented mindset and the ability to assess and improve documentation workflows are critical to success in this role. 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 Portuguese (reading and writing) is required to create, review, and maintain Portuguese‑language source documentation for Brazil‑based studies. 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:  

• Education & Experience:
  • 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 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.
• Certifications (Preferred but Not Required):
  • 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.

How We Work Together

• Location: Remote within Brazil
• Travel: Minimal (<10%), planned in advance.

Benefits & Perks

• Paid Time Off (PTO) and Company Paid Holidays
• Medical, dental, and vision insurance plan options