Job Description
Join BioNova Therapeutics at the forefront of pharmaceutical innovation as a Senior Clinical Research Associate. We're pioneering groundbreaking treatments in oncology and immunology, and we need your expertise to ensure our clinical trials meet the highest standards of excellence. Located in Cambridge's thriving biotech hub, you'll collaborate with world-renowned scientists and contribute to therapies that transform patient lives. Our culture combines cutting-edge science with unwavering commitment to ethical practices, offering unparalleled growth opportunities in a dynamic environment.
Responsibilities
- Oversee end-to-end clinical trial management from protocol design to study closure
- Ensure compliance with FDA regulations, ICH-GCP, and company SOPs
- Lead site initiation, monitoring, and audit activities across multiple global sites
- Manage investigator relationships and resolve site-specific operational challenges
- Analyze clinical data and prepare regulatory submissions for FDA/EMA
- Mentor junior CRAs and contribute to process improvement initiatives
Qualifications
- Master's degree in Life Sciences, Pharmacy, or related field (PhD preferred)
- 5+ years of clinical research experience with Phase II-III trials
- Certified Clinical Research Associate (CCRA) or equivalent certification
- Proven expertise in oncology or immunology therapeutic areas
- Advanced proficiency in EDC systems (e.g., Medidata Rave, Veeva Vault)
- Exceptional problem-solving skills and regulatory knowledge
- Strong leadership experience managing cross-functional teams