Job Description
Join BioNovate Therapeutics, a pioneering force in pharmaceutical innovation, as we develop groundbreaking treatments for rare diseases. Our Boston-based research hub combines cutting-edge science with compassionate patient care. As a Senior Clinical Research Associate, you'll lead pivotal trials that transform lives and shape the future of medicine. We offer collaborative research environments, competitive compensation, and opportunities to work with world-class scientists. Why join us? Flexible hybrid work, comprehensive benefits, and career growth in a mission-driven organization.
Responsibilities
- Design and execute clinical trial protocols ensuring GCP/ICH compliance
- Monitor investigational sites for protocol adherence and data integrity
- Lead cross-functional teams including medical, regulatory, and biostatistics
- Manage trial budgets, timelines, and vendor relationships
- Analyze safety data and prepare regulatory submissions
- Mentor junior associates and optimize clinical processes
- Present findings at scientific conferences and internal reviews
Qualifications
- MS/PhD in life sciences, pharmacy, or related field with 5+ years clinical research experience
- Certified Clinical Research Associate (CCRA) or equivalent certification
- Proven expertise in oncology/neurology therapeutic areas
- Advanced proficiency in eCRF systems (e.g., Medidata Rave, Veeva Vault)
- Strong knowledge of FDA/EMA regulations and ICH guidelines
- Exceptional problem-solving skills and attention to detail
- Experience managing global Phase II/III trials
- Excellent communication and stakeholder management abilities