Job Description
Join our pioneering team at BioPharm Innovations Inc., where we're accelerating breakthrough therapies for global health challenges. As a Senior Clinical Research Associate, you'll lead critical trials in our state-of-the-art Princeton facility, collaborating with cross-functional teams to ensure regulatory compliance and data integrity. We offer a dynamic environment with cutting-edge technology, comprehensive benefits, and opportunities for professional growth in the heart of pharmaceutical innovation.
Responsibilities
- Design, monitor, and execute Phase I-III clinical trials adhering to ICH-GCP standards
- Lead site initiation, monitoring visits, and closeout activities across 8-10 investigational sites
- Ensure protocol compliance and regulatory documentation accuracy (FDA, EMA)
- Manage clinical data systems and resolve discrepancies within CDMS platforms
- Collaborate with medical, biostatistics, and regulatory teams for trial optimization
- Prepare and submit regulatory submissions and safety reports
- Mentor junior CRAs and conduct SOP training for investigative staff
Qualifications
- Bachelor's degree in Life Sciences, Pharmacy, or related field (Master's preferred)
- 5+ years of clinical research experience with 2+ years in CRA roles
- Certified Clinical Research Associate (CCRA) or equivalent certification
- Expertise in oncology or immunology therapeutic areas
- Proven track record of managing multi-center trials
- Advanced proficiency in EDC systems (e.g., Medidata Rave) and CTMS platforms
- Strong knowledge of 21 CFR Part 312 and ICH-GCP guidelines
- Exceptional communication skills for site investigator relationships