Job Description
Join BioPharm Innovations Inc. at the forefront of medical breakthroughs as a Senior Clinical Research Associate. Lead pivotal clinical trials that transform patient lives while advancing your career in a dynamic, research-driven environment. Our state-of-the-art facilities in Princeton's biotech corridor offer unparalleled opportunities to collaborate with industry leaders and shape the future of pharmaceutical innovation.
We offer comprehensive benefits, flexible work arrangements, and a culture that values scientific excellence and professional growth. Be part of a team committed to delivering life-changing therapies with integrity and precision.
Responsibilities
- Design, implement, and oversee Phase I-IV clinical trials ensuring adherence to FDA/ICH-GCP standards
- Manage site relationships, monitor trial progress, and resolve protocol deviations proactively
- Analyze clinical data and prepare comprehensive regulatory submissions for FDA/EMA approvals
- Lead cross-functional teams including biostatisticians, medical writers, and quality assurance specialists
- Maintain real-time trial documentation in electronic systems (e.g., Medidata Rave)
- Present trial results to stakeholders and contribute to strategic decision-making
Qualifications
- Master's degree in Life Sciences, Pharmacy, or related field (PhD preferred)
- 5+ years of clinical research experience with at least 2 years in CRA or monitoring roles
- Certified Clinical Research Professional (CCRP) or equivalent certification required
- Proven expertise in oncology or rare disease therapeutic areas
- Advanced proficiency in clinical trial management software and regulatory databases
- Exceptional problem-solving skills and attention to regulatory compliance
- Strong leadership experience managing complex multi-site trials