Job Description
Join BioVita Innovations, a leader in cutting-edge pharmaceutical research, as a Senior Clinical Research Associate. Based in Cambridge's biotech hub, you'll drive the development of life-changing therapies through rigorous clinical trials. We offer a collaborative environment, competitive benefits, and opportunities to impact global healthcare. If you're passionate about advancing medical science and possess deep regulatory expertise, we want to meet you.
Responsibilities
- Oversee clinical trial execution at multiple sites, ensuring protocol adherence and GCP compliance
- Manage site relationships, conduct monitoring visits, and resolve site-specific issues
- Coordinate with CROs, vendors, and internal stakeholders to maintain trial timelines
- Analyze clinical data, prepare regulatory documents, and support FDA/EMA submissions
- Mentor junior CRAs and contribute to process optimization initiatives
- Lead risk-based monitoring strategies and implement quality management systems
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 ICH-GCP, FDA regulations, and clinical trial protocols
- Strong data management and medical terminology knowledge
- Exceptional communication skills for cross-functional collaboration
- Experience with EDC systems (e.g., Medidata Rave) and risk-based monitoring