Job Description
Join BioPharm Innovations Inc., a trailblazer in biopharmaceutical research, as we pioneer next-generation therapies. We seek a Senior Clinical Research Associate to lead pivotal clinical trials that transform patient outcomes. In this role, you'll collaborate with cross-functional teams to ensure regulatory compliance and data integrity while driving innovation in drug development. Our Cambridge hub offers cutting-edge labs and a culture of scientific excellence. Benefits include competitive equity, comprehensive health coverage, and flexible work arrangements.
Responsibilities
- Design and execute clinical trial protocols ensuring GCP/ICH compliance
- Monitor investigational sites for protocol adherence and data quality
- Liaise with regulatory agencies and ethics committees for submissions
- Analyze clinical data and prepare regulatory documentation
- Mentor junior CRAs and conduct site management training
- Collaborate with biostatistics and medical teams on trial endpoints
- Implement risk-based monitoring strategies for operational efficiency
Qualifications
- Bachelor's degree in Life Sciences, Pharmacy, or related field (Master's preferred)
- 5+ years of clinical research experience with Phase II-III trials
- Certified Clinical Research Associate (CCRA) certification required
- Proficiency in EDC systems (e.g., Medidata Rave) and CTMS
- Strong knowledge of FDA, EMA, and ICH-GCP guidelines
- Exceptional problem-solving and site management skills
- Experience in rare disease or oncology trials preferred
- Valid driver's license for site visits (25% travel required)