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Universal Diagnostics S.A. · 10 hours ago

Senior Clinical Research Associate

United States

Full-time

Remote

Senior Level

5+ years exp

Universal Diagnostics S.A. is an international company focused on developing novel diagnostic tests for early cancer detection. They are seeking a Senior Clinical Research Associate to lead clinical trials, ensuring high-quality execution and compliance with regulatory standards.

BiopharmaBiotechnologyMedical

Responsibilities

Occasionally, lead day-to-day operational management of assigned clinical studies from start-up through close-out

Develop, review, and maintain essential study documents (monitoring plans, manuals, trackers)

Manage study timelines, deliverables, and milestones to ensure high-quality execution

Support budget development, contract review, and vendor selection as needed

Conduct site qualification, initiation, routine monitoring, and close-out visits to ensure subject safety, data integrity, and protocol compliance

Provide ongoing guidance and performance oversight to investigative sites; identify and escalate site or data issues

Review, query, and reconcile clinical data; ensure timely resolution of outstanding issues

Ensure site documentation meets regulatory and audit readiness standards

Conduct site qualification, initiation, routine monitoring, and close-out visits to ensure subject safety, data integrity, and protocol compliance

Provide ongoing guidance and performance oversight to investigative sites; identify and escalate site or data issues

Review, query, and reconcile clinical data; ensure timely resolution of outstanding issues

Ensure site documentation meets regulatory and audit readiness standards

Qualification

Clinical research experienceICH-GCP knowledgeVendor oversightOncology experienceCTMS proficiencyEDC proficiencyETMF proficiencyCommunication skillsProblem-solving skillsDecision-making skillsRelationship-building skillsAdaptability