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Revvity · 3 months ago

Senior Clinical Research Associate (Project Lead)

United States

Full-time

Remote

Senior Level

5+ years exp

Revvity is a developer and provider of end-to-end solutions designed to help scientists, researchers, and clinicians solve the world’s greatest health challenges. They are seeking a Senior Clinical Research Associate (Sr. CRA) to support global In Vitro Diagnostic (IVD) clinical trials, involving the full lifecycle of clinical studies including site startup, monitoring, data oversight, and regulatory submissions.

Health CareLife Science

No H1B

Responsibilities

Contribute to study planning, feasibility, and protocol development

Identify, evaluate, and activate clinical trial sites

Support contract and budget coordination during site startup

Serve as a primary point of contact for site staff throughout the study

Conduct site qualification, initiation, interim monitoring, and close-out visits Ensure compliance with protocol, ICH-GCP, FDA, and applicable local and global regulations

Verify informed consent and assent processes and patient protections, including pediatric populations

Apply risk-based monitoring strategies and escalate issues when needed

Perform source document verification, CRF and eCRF review, and query resolution

Monitor study databases for accuracy, completeness, and data integrity

Collaborate with data management and biostatistics teams to resolve discrepancies

Work closely with Global Clinical Affairs colleagues, regulatory, and operations teams to support study deliverables

Provide input into study documents and clinical operations planning

Qualification

Clinical research experienceCTMS proficiencyEDC proficiencyRegulatory submissions experiencePediatric research backgroundOrganizational skillsMultilingual capabilitiesCommunication skillsProblem-solving skillsCross-functional collaboration