Job Description
Join our pioneering team at BioPharm Innovations, where we're revolutionizing drug development through cutting-edge clinical research. We seek a dedicated Senior Clinical Research Associate to lead critical trials for our next-generation therapeutics. This role offers the opportunity to shape the future of medicine while working in a collaborative, innovation-driven environment. Our Princeton campus provides state-of-the-art facilities and a culture that values scientific excellence and professional growth.
Responsibilities
- Design, implement, and monitor Phase I-III clinical trials ensuring compliance with FDA/ICH-GCP standards
- Lead site selection, initiation, and management of investigational sites across North America
- Conduct comprehensive site audits, source data verification, and risk-based monitoring
- Collaborate with cross-functional teams to develop study protocols and clinical trial documentation
- Analyze clinical data and prepare regulatory submissions for FDA/EMA approvals
- Mentor junior CRAs and contribute to process improvement initiatives
Qualifications
- Master's degree in Pharmacy, Life Sciences, or Clinical Research with 5+ years of CRA experience
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Proven track record in managing oncology or immunology trials
- Expertise in EDC systems (Medidata Rave, Oracle InForm)
- Strong knowledge of FDA 21 CFR Part 820 and ISO 13485 compliance
- Exceptional problem-solving skills and attention to regulatory detail
- Ability to travel 30% for site visits and conferences