We are seeking a detail-oriented and dependable contract Clinical Trial Data Entry Coordinator to support clinical trial operations by ensuring the accurate and timely entry of study data into Electronic Data Capture (EDC) systems. Based in São Paulo, this role operates under the supervision of local site staff and works closely with clinical research coordinators, investigators, and sponsor monitors to ensure high-quality data that meets regulatory and protocol requirements.
Key Responsibilities
- Perform accurate and timely data entry into sponsor-designated EDC systems in accordance with protocol specifications and timelines.
- Verify consistency between source documents and case report forms (CRFs); flag discrepancies when necessary.
- Collaborate with study coordinators and clinical staff to resolve data queries and ensure data completeness.
- Maintain compliance with Good Clinical Practice (GCP), local ANVISA regulations, and international guidelines (ICH-GCP).
- Track all data entry activities using study-specific documentation tools.
- Support preparation for site monitoring visits, audits, and regulatory inspections.
- Maintain strict confidentiality of patient data and study records.
Qualifications
- Ensino médio completo (high school diploma) required; higher education in health sciences, life sciences, or related field preferred.
- Previous experience in data entry, preferably in a clinical research or healthcare environment.
- Familiarity with EDC platforms such as Medidata Rave, REDCap, Oracle Inform, or equivalent is an advantage.
- Strong attention to detail and accuracy in data handling.
- Good organizational and time-management skills.
- Ability to communicate effectively with team members and external monitors.
- Basic knowledge of GCP and ANVISA regulatory requirements is a plus.
- Proficiency in Portuguese; basic English reading ability preferred due to international documentation.
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