Job Description
Join BioVita Therapeutics, a leader in innovative drug discovery, as we pioneer next-generation therapies for rare diseases. We're seeking a meticulous Senior Clinical Research Associate to oversee critical Phase II-III trials, ensuring compliance with global regulatory standards while driving impactful patient outcomes. Our Cambridge hub offers cutting-edge laboratories and collaborative partnerships with MIT and Harvard Medical School.
Responsibilities
- Design, implement, and monitor multi-site clinical trials across North America and EU
- Ensure protocol adherence and GCP compliance through site audits and documentation review
- Lead cross-functional teams including biostatisticians, medical writers, and regulatory affairs
- Analyze clinical data and prepare regulatory submissions for FDA/EMA approvals
- Manage investigational product logistics and vendor relationships
- Mentor junior CRAs and optimize clinical trial workflows
Qualifications
- Master's degree in Pharmacy, Life Sciences, or related field (PhD preferred)
- 5+ years clinical research experience with Phase II-III trials
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Expertise in FDA/EMA regulations and ICH-GCP guidelines
- Proven track record in oncology or rare disease trials
- Advanced proficiency in EDC systems (e.g., Medidata Rave) and SAS/Python
- Exceptional problem-solving skills for protocol deviations and safety reporting