Job Description
Join BioGen Innovations, a leader in cutting-edge pharmaceutical research, as we pioneer breakthrough therapies for global health challenges. We seek a passionate Senior Clinical Research Associate to drive our clinical trials from conception to completion. In this pivotal role, you'll ensure protocol adherence, regulatory compliance, and data integrity while collaborating with multidisciplinary teams. Our Boston hub offers state-of-the-art facilities and an environment where scientific excellence meets innovation.
Responsibilities
- Design and execute clinical trial protocols ensuring FDA/ICH-GCP compliance
- Monitor investigational sites to maintain protocol integrity and data quality
- Spearhead site selection, initiation, and closeout processes
- Analyze clinical data and prepare regulatory submissions for FDA/EMA
- Liaise with CROs, investigators, and ethics committees
- Mentor junior CRAs and optimize clinical operations workflows
Qualifications
- Master's degree in Pharmacy, Life Sciences, or Clinical Research with 5+ years CRA experience
- Certified CRA (CCRA) or equivalent certification required
- Proven track record in Phase II-III clinical trials
- Expertise in FDA regulations, ICH-GCP, and clinical data management
- Exceptional problem-solving and cross-functional communication skills
- Experience with EDC systems (e.g., Medidata Rave) and risk-based monitoring