Job Description
Join BioVita Innovations, a leader in pioneering pharmaceutical breakthroughs, as we revolutionize patient care through cutting-edge therapies. We seek a meticulous Senior Clinical Research Associate to drive excellence in clinical trial execution across our oncology portfolio. This hybrid role (3 days onsite) offers the opportunity to shape regulatory strategies while collaborating with world-class scientists and regulatory experts. Our Cambridge hub sits at the heart of America's biotech corridor, offering unparalleled networking opportunities and competitive benefits including comprehensive health coverage and professional development stipends.
Responsibilities
- Oversee Phase I-III clinical trial execution across 15+ investigational sites, ensuring protocol adherence and regulatory compliance
- Conduct site monitoring visits, source data verification, and audit preparation with 99% data accuracy
- Develop and maintain essential regulatory documentation (IB updates, safety reports, investigator brochures)
- Liaise with FDA, EMA, and other global health authorities to ensure alignment on trial design endpoints
- Lead cross-functional teams in risk-based monitoring strategy implementation and site selection
- Mentor junior CRAs and contribute to continuous process improvement initiatives
Qualifications
- Bachelor's degree in Life Sciences, Pharmacy, or related field; Master's preferred
- 5+ years of clinical research experience with 2+ years in oncology trials
- Certified Clinical Research Associate (CCRA) or equivalent certification required
- Proficiency in eCRF systems (Medidata Rave) and risk-based monitoring methodologies
- Demonstrated expertise in GCP/GMP regulations and ICH guidelines
- Exceptional problem-solving skills with complex site management scenarios
- Ability to travel 40% domestically for site monitoring and audits