Job Description
Join BioVita Therapeutics as a Senior Clinical Research Associate and shape the future of healthcare innovation. We're seeking a dedicated professional to lead clinical trials for groundbreaking therapies in oncology and rare diseases. Collaborate with cross-functional teams to ensure protocol compliance, data integrity, and regulatory excellence while contributing to life-changing treatments. Enjoy competitive compensation, comprehensive benefits, and a dynamic work environment in Boston's premier biotech hub.
Responsibilities
- Oversee clinical trial execution across multiple sites, ensuring adherence to GCP and FDA regulations
- Manage site monitoring, source data verification, and vendor relationships
- Lead protocol development and amendments with cross-functional teams
- Analyze clinical data and prepare regulatory submissions (IND/CTA)
- Mentor junior CRAs and implement process improvements
- Conduct risk-based monitoring and audit readiness activities
Qualifications
- Bachelor's degree in life sciences, nursing, or related field (Master's preferred)
- 5+ years of clinical research experience with 2+ in CRA roles
- Certified Clinical Research Associate (CCRA) or equivalent certification
- Proven expertise in oncology or rare disease trials
- Strong knowledge of ICH-GCP, FDA, and EMA regulations
- Exceptional data management and audit documentation skills
- Ability to travel up to 40% domestically