Job Description
Join BioPharm Innovations, a leader in cutting-edge pharmaceutical research, as we pioneer next-generation therapies for global health challenges. We seek a Senior Clinical Research Associate to lead pivotal clinical trials, ensuring compliance with FDA and GCP standards while driving innovation in drug development. This role offers the opportunity to make a tangible impact on patient outcomes while working with world-class scientists in our state-of-the-art Princeton facility. Enjoy competitive compensation, comprehensive benefits, and a collaborative culture that values scientific excellence and professional growth.
Responsibilities
- Design, implement, and monitor Phase II-III clinical trials across multiple therapeutic areas
- Ensure protocol compliance and regulatory adherence (ICH-GCP, FDA, EMA)
- Manage site relationships, conduct site initiation/monitoring visits, and resolve study deviations
- Analyze clinical data, prepare regulatory submissions, and contribute to study reports
- Mentor junior CRAs and collaborate with cross-functional teams (medical, biostatistics, regulatory)
- Lead risk-based monitoring strategies and implement eClinical solutions
- Represent the company at investigator meetings and external conferences
Qualifications
- Master's degree in life sciences, pharmacy, or related field (PhD preferred)
- 5+ years of clinical research experience with 2+ years in CRA roles
- Therapeutic area expertise in oncology, immunology, or rare diseases
- Certified CRA (ACRP or SoCRA) or willingness to obtain within 6 months
- Proficiency in eClinical systems (Veeva, Medidata Rave) and risk-based monitoring
- Demonstrated success in managing complex multi-site trials
- Strong problem-solving skills with attention to regulatory detail
- Excellent communication abilities for stakeholder engagement