Senior Clinical Research Associate – Project Lead

Job not on LinkedIn

October 3

🍂 Massachusetts – Remote

Although this job is listed in Massachusetts, this company may be open to hiring remote in other states.

⏰ Full Time

🟠 Senior

🔬 Research Analyst

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Revvity

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Biotechnology • Pharmaceuticals • Healthcare Insurance

Revvity is a science-based solutions company that leverages innovation across life sciences and diagnostics to improve lives everywhere. The company serves a diverse customer base, including academia, pharma/biotech, clinical laboratories, and healthcare professionals. Its extensive range of products and services includes genomic analysis, clinical diagnostics, cell and gene therapy, drug discovery, precision medicine, and advanced automation solutions. Revvity is committed to empowering scientists with cutting-edge tools and comprehensive solutions to enhance research and development, diagnostics, and clinical testing. With a focus on accelerating time to market while ensuring quality, Revvity is dedicated to revolutionizing next-generation breakthroughs in healthcare and life sciences.

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• 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

🎯 Requirements

• Bachelor’s degree in a scientific or healthcare field or RN/BSN AND a minimum 5 years of clinical research experience including independent monitoring • Proficiency with CTMS, EDC, and Microsoft Office Suite • Strong organizational skills with the ability to adapt quickly and manage competing priorities • Excellent communication and problem-solving skills • Ability to collaborate effectively in a global, cross-functional environment • Ability to travel up to 25 percent for site visits and team meetings • Must possess U.S. work authorization • Demonstrated ability to manage clinical sites across multiple phases of a study • Experience in Type 1 Diabetes, infectious diseases, or newborn screening clinical studies • Background in pediatric and adolescent research including assent, consent, and age-appropriate protections • Prior experience supporting FDA or IVDR submissions • Multilingual capabilities are a plus

🏖️ Benefits

• Medical, Dental, and Vision Insurance Options • Life and Disability Insurance • Paid Time-Off • Parental Benefits • Compassionate Care Leave • 401k with Company Match • Employee Stock Purchase Plan