Job Description
Join BioPharm Innovations, a leader in cutting-edge pharmaceutical research, as we pioneer next-generation therapies to transform global healthcare. We seek a dynamic Senior Clinical Research Associate to spearhead pivotal clinical trials, ensuring regulatory compliance and data integrity while driving innovation in drug development. Collaborate with cross-functional teams to accelerate the delivery of life-changing treatments to patients worldwide.
Responsibilities
- Design, implement, and monitor Phase I-IV clinical trials across diverse therapeutic areas
- Ensure adherence to FDA/ICH-GCP guidelines and protocol compliance through site visits and audits
- Lead vendor management relationships with CROs and investigative sites globally
- Analyze complex clinical data and prepare regulatory submissions for FDA/EMA approval
- Mentor junior CRAs and optimize clinical trial workflows using ePRO/eCRF systems
- Represent the company at investigator meetings and industry conferences
Qualifications
- Master's degree in Pharmacy, Nursing, or Life Sciences with 5+ years clinical research experience
- Certified Clinical Research Professional (CCRP) or equivalent certification required
- Proven track record in managing multi-center oncology/neurology trials
- Expertise in EDC systems (e.g., Medidata Rave, Veeva Vault) and risk-based monitoring
- Strong understanding of FDA 21 CFR Part 11 and global regulatory frameworks
- Exceptional project management skills with PMP certification preferred
- Fluency in English with bilingual (Spanish/French) capabilities a plus