Job Description
Join BioVita Innovations as a Senior Clinical Research Associate and lead groundbreaking pharmaceutical trials that transform patient outcomes. Based in Cambridge's biotech corridor, you'll drive critical studies in oncology and rare diseases while collaborating with world-class scientists and regulatory experts. We offer competitive compensation, comprehensive benefits, and opportunities for professional growth in an environment that values innovation and integrity.
Responsibilities
- Oversee end-to-end clinical trial execution across multiple sites, ensuring protocol compliance and data integrity
- Conduct site monitoring visits, source data verification, and GCP audits to maintain regulatory standards
- Manage relationships with CROs, investigators, and vendors to ensure trial milestones are met
- Analyze clinical data and prepare regulatory submissions for FDA/EMA approvals
- Mentor junior CRAs and contribute to process optimization initiatives
- Represent BioVita at investigator meetings and industry conferences
Qualifications
- Bachelor's degree in Life Sciences, Pharmacy, or related field; Master's preferred
- 5+ years of clinical research experience with Phase II-III trials in pharmaceutical or biotech
- Certified CRA (ACRP or SoCRA) required
- Proven expertise in oncology or rare disease therapeutic areas
- Advanced knowledge of ICH-GCP, FDA/EMA regulations, and risk-based monitoring
- Exceptional data management and audit skills with CTMS/eCRF experience
- Strong leadership abilities with cross-functional team management experience