Job Description
Join BioVita Innovations, a leader in precision medicine and biopharmaceutical R&D, as a Senior Clinical Research Associate. We're seeking a passionate professional to drive our groundbreaking oncology clinical trials from Phase I to Phase III. This hybrid role (3 days onsite in Boston) offers competitive compensation, comprehensive benefits, and the opportunity to impact patient lives worldwide. Collaborate with cross-functional teams including regulatory affairs, biostatistics, and medical affairs to ensure trial integrity and regulatory compliance. Your expertise will directly contribute to accelerating life-changing therapies to market.
Responsibilities
- Design and execute clinical trial protocols ensuring alignment with FDA/EMA regulations and GCP standards
- Monitor investigational sites for protocol adherence, data integrity, and regulatory compliance
- Lead site initiation visits, routine monitoring, and close-out activities across 8-10 global sites
- Analyze clinical data for safety signals and efficacy trends, preparing comprehensive monitoring reports
- Collaborate with medical monitors on safety assessments and risk-based monitoring strategies
- Maintain trial master files and ensure audit readiness for regulatory inspections
- Mentor junior CRAs and contribute to continuous process improvements in clinical operations
Qualifications
- Bachelor's degree in life sciences, nursing, or related field (Master's preferred)
- 5+ years of clinical research experience with 2+ years in oncology trials
- Certified Clinical Research Professional (CCRP) or SOCRA certification required
- Proven expertise in FDA/EMA regulations, ICH-GCP, and clinical trial management systems (e.g., Medidata Rave)
- Exceptional data management skills with experience in EDC systems and risk-based monitoring
- Strong leadership abilities with experience mentoring junior staff and leading site management
- Excellent written/verbal communication skills for cross-functional collaboration
- Ability to travel domestically (25%) and internationally (10%) as needed