Job Description
Join BioMedic Innovations as a Senior Clinical Research Associate and drive breakthroughs in pharmaceutical innovation. We're seeking a passionate professional to lead pivotal clinical trials, ensuring regulatory compliance while advancing life-changing therapies. This hybrid role offers the chance to collaborate with world-renowned scientists and make a tangible impact on global health.
Responsibilities
- Design and execute Phase I-III clinical trials with rigorous protocol adherence
- Monitor investigational sites for GCP compliance and data integrity
- Lead cross-functional teams of biostatisticians, medical writers, and regulatory specialists
- Prepare FDA submissions and ensure audit readiness
- Analyze clinical data to generate actionable insights for trial optimization
- Manage vendor relationships and oversee outsourced trial activities
Qualifications
- MS/PhD in Life Sciences, Pharmacy, or related field with 5+ years clinical research experience
- Certified CRA (ACRP/SoCRA) or equivalent certification required
- Proven expertise in oncology or immunotherapy trials preferred
- Advanced proficiency in EDC systems (Medidata Rave, Veeva Vault)
- Exceptional knowledge of ICH-GCP and 21 CFR Part 820
- Strong strategic planning and stakeholder management skills