Job Description
Join our cutting-edge pharmaceutical team at BioPharm Innovations Inc., where we pioneer breakthrough therapies to transform global healthcare. As a Senior Clinical Research Associate, you'll lead pivotal clinical trials ensuring regulatory compliance and data integrity while collaborating with cross-functional teams to accelerate drug development. Our culture champions innovation, scientific excellence, and career growth in a state-of-the-art research facility.
Responsibilities
- Oversee clinical trial execution across multiple sites ensuring GCP compliance and FDA/EMA regulations
- Manage site monitoring activities, source data verification, and vendor relationships
- Develop and maintain clinical trial documentation protocols, CRFs, and IB updates
- Analyze complex trial data and prepare regulatory submissions for FDA/EMA approval
- Mentor junior CRAs and lead cross-functional project teams
- Implement risk-based monitoring strategies for protocol deviations and adverse events
Qualifications
- Master's degree in Life Sciences, Pharmacy, or related field (PhD preferred)
- 5+ years clinical research experience with 2+ years in CRA roles
- Certified CRA (CCRA) or equivalent certification required
- Proven expertise in oncology or rare disease therapeutic areas
- Advanced proficiency in eClinical systems (e.g., Medidata Rave, Veeva Vault)
- Strong knowledge of ICH-GCP, 21 CFR Part 312, and clinical trial regulations
- Exceptional problem-solving and communication skills for global stakeholder management