Job Description
Join BioNovate Therapeutics, a leader in innovative pharmaceutical solutions, as we pioneer next-generation therapies. We seek a meticulous Senior Clinical Research Associate to orchestrate complex clinical trials across multiple sites. This pivotal role ensures regulatory compliance, data integrity, and seamless collaboration with global stakeholders while advancing life-changing treatments. Work in our state-of-the-art Cambridge facility surrounded by cutting-edge biotech innovation.
Responsibilities
- Oversee clinical trial execution across 3-5 investigational sites ensuring adherence to GCP and FDA regulations
- Conduct comprehensive site monitoring visits, source document verification, and risk-based quality management
- Lead cross-functional teams including data management, biostatistics, and regulatory affairs
- Develop and maintain critical trial documentation (protocols, IBs, reports)
- Manage investigator relationships and resolve site-specific operational challenges
- Analyze clinical data trends and implement corrective/preventive actions
Qualifications
- Master's degree in Life Sciences, Pharmacy, or related field with 5+ years clinical research experience
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Proven expertise in Phase II-III oncology or rare disease trials
- Advanced knowledge of ICH-GCP, FDA 21 CFR Part 812, and international regulatory requirements
- Exceptional data management and audit trail interpretation skills
- Strong proficiency in EDC systems (e.g., Medidata Rave, Veeva Vault)