Job Description
Join BioNexus Therapeutics, a leader in innovative drug development, as we pioneer next-generation therapies for rare diseases. We're seeking a Senior Clinical Research Associate to lead critical clinical trials and ensure regulatory compliance while collaborating with cross-functional teams to bring breakthrough treatments to patients worldwide.
Responsibilities
- Design and execute clinical trial protocols with meticulous attention to FDA/EMA compliance
- Monitor investigational sites to ensure GCP standards and data integrity
- Lead site initiation visits, routine monitoring, and closeout procedures
- Analyze clinical data and prepare comprehensive study reports for regulatory submissions
- Mentor junior CRAs and coordinate cross-functional team communications
- Manage vendor relationships and clinical trial budget allocations
Qualifications
- Master's degree in Life Sciences, Pharmacy, or related field (PhD preferred)
- 5+ years of clinical research experience with Phase II-III trials
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Expertise in oncology or rare disease therapeutic areas
- Proven track record in FDA/EMA audit readiness
- Advanced proficiency in eCRF systems (Medidata Rave, Veeva Vault)
- Exceptional problem-solving skills in complex clinical environments