Job Description
Join BioVita Therapeutics at the forefront of pharmaceutical innovation as a Senior Clinical Research Associate. Lead pivotal clinical trials that transform patient outcomes while collaborating with cross-functional teams to ensure regulatory compliance and data integrity. Our Boston-based R&D hub offers state-of-the-art facilities and a culture of scientific excellence.
We seek a passionate professional to manage clinical trials from protocol design to final report submission, ensuring adherence to GCP standards and FDA regulations. Enjoy competitive compensation, comprehensive benefits, and opportunities to shape the future of medicine.
Responsibilities
- Design and execute clinical trial protocols in therapeutic areas including oncology and immunology
- Monitor investigational sites to ensure protocol compliance and data quality
- Lead vendor management and CRO oversight for multi-center studies
- Prepare regulatory submissions and maintain essential study documentation
- Analyze clinical data and contribute to risk-based monitoring strategies
- Mentor junior associates and optimize clinical trial processes
Qualifications
- Master's degree in life sciences, pharmacy, or related field (PhD preferred)
- 5+ years of clinical research experience with Phase II-III trials
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Proven expertise in oncology and immunology therapeutic areas
- Strong knowledge of ICH-GCP, FDA 21 CFR Part 812, and EMA regulations
- Advanced proficiency in electronic data capture systems (e.g., Medidata Rave)
- Exceptional communication skills for cross-functional collaboration