Clinical Data Coordinator

Job Title

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)

Requirements:

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