Specialist, Clinical Research Associate
Core
Ensures compliance of clinical study conduct with ICH/GCP and country regulations, manages assigned sites, and develops new clinical research territories.
Role type
Specialist Clinical Research Associate (Site Management & Monitoring)
Builds
Clinical research studies for pharmaceutical/biotech sponsors
Domain
Healthcare / Clinical Trials
Required skills
Clinical Site Management, Clinical Trials Monitoring, Protocol Adherence, Adverse Event Reporting, Regulatory Documentation Management, Data Quality Assurance, Site Selection & Validation, Remote Monitoring, Audit/Inspection Support, Stakeholder Communication (via careerplan.io/jobs/R419942-2-specialist-clinical-research-associate-at-msd)
Preferred skills
None stated
Technologies
CTMS, eTMF
Responsibilities
Perform on-site and remote monitoring visits to ensure data accuracy and subject safety; manage site relationships and performance; coordinate site start-up and close-out activities; collect and review regulatory documentation; communicate with investigators and site staff on protocol conduct and deviations; identify and resolve compliance issues; contribute to team knowledge as a Subject Matter Expert.
Seniority
Specialist (Individual Contributor)