[Hiring] Source Document Specialist @Care Access

Role Description

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.

Qualifications

• Bachelor’s degree in a health-related field (e.g., Life Sciences, Nursing, Public Health, or a related discipline) preferred.
• 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.
• Proficiency in Microsoft Excel, Word, SharePoint, and other digital documentation tools.

Requirements

• 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.

Benefits

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