Job Description
Join BioPharm Innovations, a leader in groundbreaking therapeutics, as we accelerate the development of life-changing treatments. We're seeking a dynamic Senior Clinical Research Associate to oversee pivotal clinical trials, ensuring regulatory compliance and data integrity while collaborating with cross-functional teams to bring innovative therapies to patients worldwide.
Responsibilities
- Design, implement, and monitor clinical trial protocols across multiple sites
- Conduct site visits, audits, and vendor management to ensure GCP compliance
- Lead cross-functional teams including data managers, biostatisticians, and medical monitors
- Analyze clinical data and prepare regulatory submissions (IND/IMPD, FDA)
- Develop risk-based monitoring strategies and quality management systems
- Mentor junior CRAs and contribute to process optimization initiatives
Qualifications
- Master's degree in life sciences, pharmacy, or related field (PhD preferred)
- 5+ years clinical research experience with Phase II-III trials
- Certified CRA (ACRP/SoCRA) or equivalent certification required
- Expertise in ICH-GCP, FDA/EMA regulations, and risk-based monitoring
- Strong proficiency in EDC systems (e.g., Medidata Rave, Veeva Vault)
- Demonstrated leadership in complex multi-site trials
- Exceptional problem-solving and stakeholder communication skills