Fortrea
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Biotech
Manages and monitors clinical trial sites according to SOPs, ICH GCP, regulatory requirements, study protocols, and monitoring plans. Conducts site visits, reviews source documents and eCRFs, verifies informed consent and data integrity, resolves queries, maintains regulatory and trial documentation, tracks investigational product inventory, follows up on safety events, supports site initiation and training, and ensures audit readiness. The role requires independent site monitoring, strong organization, matrix collaboration, and travel to study sites approximately 60% of the time.
One Month AgoSaved
Biotech
The Senior Clinical Research Associate I monitors clinical study sites, ensures compliance, manages data integrity, and mentors junior staff while traveling extensively to support clinical trials.
Biotech
Coordinate and manage site start-up activities for clinical trials including site identification, outreach, regulatory/ethics submissions, document collection and quality review, contract and budget negotiation, support for SIVs, TMF maintenance, and stakeholder communication to ensure compliant and timely site activation.
