Job Description
Join BioVita Therapeutics, a leader in cutting-edge pharmaceutical innovation, as we pioneer next-generation therapies that transform patient lives. We seek a passionate Senior Clinical Research Associate to drive our Phase I-III clinical trials from protocol to submission. You'll collaborate with cross-functional teams in our state-of-the-art Cambridge facility, ensuring regulatory compliance and data integrity while mentoring junior CRAs. This role offers unparalleled growth opportunities in a dynamic, research-driven environment where your expertise directly impacts global health outcomes.
Responsibilities
- Monitor clinical trial sites for protocol adherence and regulatory compliance (FDA, EMA, ICH-GCP)
- Conduct site initiation, interim monitoring, and closeout visits with 100% source data verification
- Manage site relationships, training, and performance metrics across 8-10 investigational sites
- Lead clinical trial documentation (CRFs, SAEs, amendments) with zero tolerance for deviations
- Collaborate with biostatisticians on data quality assessments and query resolution
- Mentor junior CRAs on SOPs, audit preparation, and risk-based monitoring strategies
- Represent BioVita at investigator meetings and regulatory authority inspections
Qualifications
- Bachelor's degree in Life Sciences, Pharmacy, or related field (Master's preferred)
- 5+ years of clinical monitoring experience in Phase II-III trials (oncology focus required)
- CRA certification (ACRP or SoCRA) and current GCP/ICH knowledge
- Proven track record of managing 15+ sites with 95%+ audit compliance
- Advanced proficiency in eCRF systems (Medidata Rave, Veeva Vault) and CTMS
- Exceptional problem-solving skills in resolving site-specific data discrepancies
- Strong leadership background in cross-functional project teams
- Willingness to travel 40-50% (domestic/international)