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T45 Labs · 1 month ago

Senior Clinical Research Associate - VahatiCor

Santa Clara, CA

Full-time

Onsite

Senior Level

$133K/yr - $179K/yr

5+ years exp

T45 Labs is a medical device company focused on developing breakthrough cardiovascular technologies. The Senior Clinical Research Associate will provide advanced monitoring oversight, site engagement, documentation review, and inspection-readiness support across all phases of cardiovascular clinical studies.

ManufacturingMedicalMedical Device

No H1B

Responsibilities

Lead monitoring activities to ensure compliance with protocols, SOPs, FDA regulations, and ICH/GCP guidelines

Conduct qualification, initiation, interim, and close-out visits (in-person and remote)

Perform source data verification, eCRF review, and oversee query resolution

Maintain strong relationships with investigational sites to support enrollment, data quality, and overall study performance

Provide timely issue identification, escalation, and follow-up

Review and support development of study materials such as monitoring plans, site tools, and trackers

Ensure TMF quality, accuracy, and completeness

Contribute to vendor oversight activities and quality checks

Support audit and inspection-readiness processes

Work closely with CTMs, data management, clinical leadership, and vendors

Support investigational product tracking and reconciliation

Participate in study team meetings and provide operational insight

Qualification

Clinical Research AssociateMedtech experienceFDA regulationsICH/GCP guidelinesSite managementDocumentation skillsCommunication skillsTeam collaborationProblem-solving