Job Description
Join NovaBio Therapeutics at the forefront of innovative drug development! We're seeking a meticulous Senior Clinical Research Associate to oversee complex clinical trials across multiple therapeutic areas. You'll ensure protocol compliance, manage site relationships, and drive regulatory excellence in our Cambridge, MA headquarters. This role offers hybrid flexibility and opportunities to shape the future of medicine through cutting-edge research.
Responsibilities
- Monitor clinical trial sites for protocol compliance and regulatory adherence
- Conduct site visits, audits, and vendor management activities
- Manage clinical trial documentation and regulatory submissions
- Collaborate with cross-functional teams on trial design and execution
- Analyze trial data and prepare comprehensive regulatory reports
- Mentor junior CRAs and contribute to process improvements
Qualifications
- Bachelor's degree in Life Sciences, Pharmacy, or related field (Master's preferred)
- 5+ years of clinical research experience in pharmaceutical/biotech
- Certified CRA (CCRA) or equivalent regulatory certification
- Deep knowledge of ICH-GCP, FDA regulations, and clinical trial protocols
- Proven experience with EDC systems and clinical trial management software
- Exceptional attention to detail and documentation skills
- Strong interpersonal and stakeholder management abilities