Job Description
Join BioNova Pharmaceuticals, a leader in innovative therapeutics, as we advance groundbreaking treatments for chronic diseases. We seek a highly motivated Senior Clinical Research Associate to oversee pivotal clinical trials ensuring regulatory compliance and data integrity. This hybrid role offers the opportunity to shape the future of medicine while collaborating with world-class scientists and regulatory experts.
Responsibilities
- Manage site monitoring and clinical trial execution per GCP/ICH guidelines
- Oversee protocol implementation and resolve site-specific issues
- Conduct source data verification and ensure regulatory compliance
- Liaise with FDA, IRBs, and global clinical operations teams
- Analyze clinical data and prepare regulatory documentation
- Mentor junior CRAs and optimize trial management processes
- Lead cross-functional project meetings and stakeholder communications
Qualifications
- BS/MS in Life Sciences, Pharmacy, or related field (PhD preferred)
- 5+ years clinical research experience with Phase II-III trials
- ICH-GCP certification and FDA/EMA regulatory knowledge
- Proven expertise in oncology or autoimmune disease trials
- Strong data management and EDC system proficiency (Medidata Rave)
- Exceptional problem-solving and cross-cultural communication skills
- Ability to travel 30-40% for site monitoring