Job Description
Join BioVance Therapeutics, a leader in cutting-edge pharmaceutical innovation, as we pioneer next-generation therapies for rare diseases. We're seeking a dedicated Clinical Research Associate to drive our Phase I-III clinical trials to success. In this pivotal role, you'll collaborate with cross-functional teams to ensure regulatory compliance, data integrity, and patient safety while advancing breakthrough treatments that transform lives. Enjoy a competitive compensation package, comprehensive benefits, and the opportunity to shape the future of medicine in our state-of-the-art Cambridge facility.
Responsibilities
- Monitor clinical trial sites for protocol adherence and regulatory compliance (GCP/ICH guidelines)
- Conduct site visits, source document verification, and data quality audits
- Liaise with investigators to resolve protocol deviations and ensure timely study milestones
- Prepare and submit regulatory documentation to FDA and ethics committees
- Analyze clinical data and prepare comprehensive site visit reports
- Train site staff on SOPs, trial protocols, and safety reporting procedures
- Collaborate with CROs and internal teams to optimize trial efficiency
Qualifications
- Bachelor's degree in Life Sciences, Pharmacy, or related field (Master's preferred)
- 3+ years of clinical research experience in pharmaceutical/biotech
- CRA certification (ACRP or SoCRA) or equivalent experience
- Proven track record of managing Phase I-III trials
- Strong knowledge of FDA regulations, ICH-GCP, and clinical trial processes
- Exceptional communication skills for stakeholder management
- Proficiency in EDC systems (e.g., Medidata Rave, Veeva Vault)
- Ability to travel 25-30% domestically