Job Description
Join BioNova Therapeutics, a trailblazer in innovative drug development, as we pioneer next-generation therapies for rare diseases. Our Cambridge-based hub combines cutting-edge research with agile clinical operations to accelerate life-changing treatments. As a Senior Clinical Research Associate, you'll lead pivotal trials that directly impact patient outcomes while collaborating with world-class scientists and regulatory experts. We offer comprehensive benefits, flexible work arrangements, and a culture that celebrates scientific excellence and professional growth.
Responsibilities
- Design and execute complex clinical trial protocols ensuring compliance with FDA/ICH-GCP standards
- Oversee site monitoring activities, including source data verification and vendor management
- Analyze clinical data to identify trends and recommend protocol modifications
- Collaborate with cross-functional teams to resolve operational and regulatory challenges
- Prepare regulatory submissions and maintain audit-ready documentation systems
- Mentor junior CRAs and contribute to process improvement initiatives
Qualifications
- Master's degree in Pharmacy, Life Sciences, or related field with 5+ years clinical research experience
- Proven expertise in monitoring Phase II-III oncology or rare disease trials
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Advanced proficiency in electronic data capture systems (e.g., Medidata Rave)
- Demonstrated success in managing complex site relationships and vendor contracts
- Strong understanding of FDA 21 CFR Part 11 and global regulatory frameworks
- Exceptional problem-solving skills with attention to detail