Job Description
Join BioVance Therapeutics, a pioneering biopharmaceutical company dedicated to transforming patient outcomes through innovative therapies. We seek a Senior Clinical Research Associate to lead complex clinical trials and drive our mission forward. This role offers the opportunity to work at the intersection of cutting-edge science and regulatory excellence in Cambridge's vibrant biotech ecosystem.
As a key member of our Clinical Operations team, you'll ensure protocol integrity, maintain GCP compliance, and collaborate with cross-functional stakeholders to accelerate drug development. Our culture emphasizes scientific rigor, patient-centricity, and professional growth.
Responsibilities
- Oversee site management and monitoring for Phase I-III clinical trials
- Ensure protocol adherence and regulatory compliance (FDA/ICH-GCP)
- Lead vendor management and clinical trial documentation processes
- Coordinate cross-functional teams (medical, regulatory, data management)
- Conduct site initiation, monitoring, and closeout visits
- Analyze clinical data and prepare regulatory submissions
- Mentor junior CRAs and optimize trial workflows
Qualifications
- Master's degree in life sciences, pharmacy, or related field
- 5+ years of clinical research experience with Phase II-III trials
- Certified CRA (ACRP or SoCRA) preferred
- Deep knowledge of FDA/ICH-GCP and regulatory requirements
- Experience with EDC systems (Medidata Rave, Veeva Vault)
- Strong problem-solving and stakeholder management skills
- Proven ability to manage complex multi-site trials