Clinical Data Coordinator

Responsibilities

• Assist in the development, testing, and validation of Electronic Data Capture (EDC) systems and Case Report Forms (CRFs)
• Support database setup activities including edit check specifications and user acceptance testing (UAT)
• Review incoming clinical data for completeness, consistency, and accuracy
• Generate, track, and resolve data queries in collaboration with clinical sites
• Maintain study documentation and data management files
• Participate in cross-functional study team meetings and data review discussions
• Support Serious Adverse Event (SAE) reconciliation and external data reconciliation (e.g., labs, central imaging)
• Ensure data management activities follow SOPs, study protocols, and regulatory standards (e.g., ICH-GCP, CDISC)

• Bachelor's degree in a life science, health science, pharmacy, public health, or related field
• Strong attention to detail, organizational, and time management skills
• Proficiency with Microsoft Office Suite (Excel, Word, PowerPoint)
• Effective written and verbal communication skills
• Ability to learn and apply technical systems and software (EDC, CTMS, etc.)
• Familiarity with clinical trial processes and Good Clinical Practice (GCP)
• Experience with EDC systems (e.g., Medidata Rave, Veeva Vault, Medrio) a plus