Job Description
Join BioGenix Innovations, a leader in cutting-edge pharmaceutical research, as we pioneer next-generation therapies for unmet medical needs. We're seeking a passionate Senior Clinical Research Associate to oversee pivotal clinical trials and ensure regulatory compliance while driving innovation in drug development. Collaborate with cross-functional teams to transform scientific breakthroughs into life-changing treatments.
Responsibilities
- Design, implement, and monitor Phase I-IV clinical trials across therapeutic areas
- Ensure adherence to FDA regulations, ICH-GCP standards, and protocol compliance
- Manage vendor relationships and clinical trial site selection/activation
- Analyze clinical data and prepare regulatory submissions for FDA/EMA approval
- Mentor junior CRAs and optimize clinical trial processes
- Represent BioGenix at investigator meetings and industry conferences
Qualifications
- Master's degree in Pharmacy, Life Sciences, or related field
- 5+ years of clinical research experience with 2+ years in CRA roles
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Proven expertise in oncology or rare disease therapeutic areas
- Advanced knowledge of FDA 21 CFR Part 312 and EMA guidelines
- Strong proficiency in eCRF systems and clinical trial management software