We work to fight poverty and achieve social justice by empowering women and girls. www.CARE.org
Source Document Specialist
Location
Brazil
Posted
72 days ago
Salary
0
Seniority
Mid Level
Job Description
Source Document Specialist
CARE
• 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.
Job Requirements
- 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.
Benefits
- Paid Time Off (PTO) and Company Paid Holidays
- Medical, dental, and vision insurance plan options
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