Job Description
Join BioInnovate Therapeutics, a pioneering force in oncology drug development, as we accelerate breakthrough therapies to combat cancer. Our Cambridge-based team operates at the intersection of cutting-edge science and compassionate patient care. As a Senior Clinical Research Associate, you'll lead pivotal clinical trials from protocol design to final FDA submission, working with world-class researchers and regulatory experts. We offer competitive benefits, flexible work arrangements, and opportunities to shape the future of medicine through rigorous clinical excellence.
Responsibilities
- Design, execute, and monitor Phase I-III clinical trials ensuring GCP compliance and data integrity
- Liaise with investigative sites, CROs, and regulatory authorities to ensure protocol adherence
- Oversee site selection, initiation visits, and monitoring activities across 10-15 trial sites
- Analyze clinical data and prepare regulatory submissions for FDA/EMA approval
- Lead cross-functional teams including biostatisticians, medical writers, and project managers
- Develop risk-based monitoring strategies and implement quality control measures
- Maintain electronic trial master files and ensure audit readiness
Qualifications
- Bachelor's degree in life sciences, nursing, or related field; Master's or PhD preferred
- 5+ years of clinical research experience with 2+ years in CRA role
- Certified Clinical Research Associate (CCRA) or ACRP/SoCRA certification
- Expert knowledge of ICH-GCP, FDA 21 CFR Part 312, and EU clinical trial regulations
- Proven experience with EDC systems (e.g., Medidata Rave) and CTMS platforms
- Strong analytical skills with ability to interpret complex clinical data
- Exceptional communication skills for stakeholder management and conflict resolution