Job Description
Join BioVita Therapeutics as a Senior Clinical Research Associate and drive innovation in life-changing therapies. We're a pioneering biopharmaceutical company dedicated to advancing patient care through cutting-edge clinical trials. In this pivotal role, you'll oversee complex Phase I-III studies, ensuring compliance with FDA/ICH-GCP standards while collaborating with cross-functional teams. Enjoy competitive compensation, comprehensive benefits, and the opportunity to shape the future of medicine in our state-of-the-art Boston facility.
Responsibilities
- Lead end-to-end clinical trial execution, including site selection, monitoring, and vendor management
- Ensure protocol adherence and regulatory compliance through proactive risk-based monitoring
- Collaborate with medical teams to resolve complex protocol deviations and data discrepancies
- Maintain electronic trial master files and audit documentation to FDA standards
- Train and mentor junior CRAs on SOPs and clinical trial methodologies
- Prepare regulatory submissions and respond to agency inquiries with precision
Qualifications
- Bachelor's degree in Life Sciences, Pharmacy, or related field (Master's preferred)
- 5+ years of clinical trial monitoring experience in pharmaceutical/biotech
- Certified CRA (CCRA) or equivalent professional certification
- Expertise in EDC systems (e.g., Medidata Rave, Veeva Vault)
- Proven track record in oncology or rare disease trials
- Strong knowledge of FDA/ICH-GCP and 21 CFR Part 11 requirements
- Exceptional problem-solving and cross-functional communication skills