FSP Clinical Trial coordinador II
Core
Coordinate and facilitate clinical trial activities, serving as a cross-functional liaison and study lead for assigned trials.
Role type
Senior Clinical Trial Coordinator
Builds
Clinical trial documentation, regulatory submissions, and study metrics reports
Domain
Clinical Research / Pharmaceutical Trials
Required skills
Clinical trial coordination, regulatory document management, eTMF maintenance, data analysis, project tracking, vendor management, translation support
Preferred skills
Bachelor's degree, 4+ years experience, knowledge of ICH GCP and country regulations, MS Office proficiency
Technologies
GoBalto, eTMF, MS Office (Word, Excel, PowerPoint), clinical trial database systems
Responsibilities
Coordinate and oversee assigned trial activities; perform file reviews and document findings; ensure tasks are completed on time and within budget; maintain study documentation and system access; process documents for client and regulatory submission; analyze study metrics and resolve documentation findings; assist with site file and supply distribution.
Seniority
Senior, hands-on IC