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Revvity · 1 week ago

Senior Clinical Research Associate (Project Lead)

United States

Full-time

Hybrid

Senior Level

$102K/yr - $128K/yr

5+ years exp

Revvity is seeking a Senior Clinical Research Associate (Sr. CRA) to support global In Vitro Diagnostic (IVD) clinical trials. The role involves the full lifecycle of clinical studies, including site startup, monitoring, data oversight, and preparation for regulatory submissions, while collaborating with a global Clinical Affairs team to improve patient care worldwide.

Health CareLife Science

No H1B

Hiring Manager

Joanna Banegas Trede MBA, MA

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 experienceVitro Diagnostic (IVD)FDA submissionsCTMS proficiencyEDC proficiencyMultilingual capabilitiesOrganizational skillsCommunication skillsProblem-solving skillsCross-functional collaboration