Job Description
Join BioVita Therapeutics, a leader in innovative pharmaceutical solutions, as a Senior Clinical Research Associate. Based in our Boston headquarters, you'll drive clinical trial excellence and contribute to groundbreaking therapies that transform patient lives. We offer a dynamic environment where your expertise in clinical trial management will directly impact the development of next-generation treatments.
Why BioVita? Our commitment to scientific rigor, collaborative culture, and employee development sets us apart. Enjoy competitive compensation, comprehensive benefits, and the opportunity to work with industry pioneers in state-of-the-art facilities.
Responsibilities
- Oversee end-to-end clinical trial execution across multiple phases (I-IV), ensuring protocol compliance and regulatory adherence
- Lead site monitoring, vendor management, and data quality assurance processes
- Collaborate with cross-functional teams (medical, regulatory, biostatistics) to drive trial milestones
- Develop and maintain comprehensive study documentation (CRFs, IBs, regulatory submissions)
- Analyze clinical data and prepare safety reports for FDA/EMA submissions
- Mentor junior associates and optimize clinical trial methodologies
- Represent BioVita at investigator meetings and industry conferences
Qualifications
- Master's degree in Pharmacy, Life Sciences, or Clinical Research (PhD preferred)
- 5+ years of clinical trial experience in pharmaceutical or CRO environment
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Proven expertise in ICH-GCP, FDA/EMA regulations, and 21 CFR Part 11 compliance
- Strong proficiency in EDC systems (e.g., Medidata Rave, Oracle Inform)
- Exceptional project management and stakeholder communication skills
- Experience with oncology or rare disease trials highly desirable
- Ability to travel domestically (20-30%)