Job Description
Join BioVance Therapeutics, a pioneering biopharmaceutical leader, as a Senior Clinical Research Associate. Shape the future of medicine by driving clinical trials for groundbreaking therapies in oncology and rare diseases. Collaborate with cross-functional teams to ensure regulatory compliance, protocol integrity, and patient safety across global trial sites.
Our Cambridge headquarters offers state-of-the-art facilities and a culture of scientific excellence. You'll leverage cutting-edge technology to accelerate drug development while mentoring junior associates and contributing to process improvements that set industry standards.
Responsibilities
- Design and execute clinical trial protocols adhering to FDA/ICH-GCP regulations
- Monitor investigational sites for protocol compliance, data quality, and regulatory adherence
- Lead site initiation, interim monitoring, and closeout visits with 100% audit readiness
- Manage clinical trial documentation including IB updates, CRFs, and safety reports
- Analyze and interpret clinical data to support regulatory submissions and decision-making
- Coordinate with CROs, vendors, and internal stakeholders to ensure trial milestones
- Mentor junior associates and implement continuous improvement initiatives
Qualifications
- Bachelor's degree in life sciences, nursing, or related field; Master's preferred
- 5+ years clinical research experience with 2+ years in CRA/lead CRA roles
- Proven expertise in oncology/rare disease trials and FDA/EMA regulations
- Certified Clinical Research Associate (CCRA) or equivalent certification
- Exceptional audit management and site relationship-building skills
- Proficiency in EDC systems (e.g., Medidata Rave, Veeva Vault)
- Ability to travel 25-30% domestically/internationally