Source Document Specialist
New
C
Care AccessClinical Research
Remote within BrazilFull-TimeMiddle
Salary not disclosed
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Job Details
- Languages
- Portuguese, English
- Experience
- Minimum of 2 years of experience
- Required Skills
- Microsoft Excel
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.
- Proficiency in Microsoft Excel, Word, SharePoint, and other digital documentation tools.
- Ability and willingness to work within eSource platforms such as CRIO.
- Fluency in Portuguese (reading and writing) for Brazil-based studies.
- Fluency in English (reading, writing, and speaking) for global team communication and review of English-language documentation.
- GCP Certification (required or obtained upon hire).
Responsibilities
- 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.
- 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.
- 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.
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