Job Description
Join BioPharm Innovations Inc., a leader in groundbreaking pharmaceutical research, as we pioneer next-generation therapies. We seek a meticulous Senior Clinical Research Associate to oversee critical trial phases, ensuring regulatory compliance and data integrity. This role offers unparalleled opportunities to impact global healthcare while collaborating with cross-functional teams in our state-of-the-art facilities.
Responsibilities
- Manage and monitor clinical trials across multiple sites, ensuring adherence to FDA/ICH-GCP guidelines
- Oversee site initiation, monitoring visits, and trial closure with comprehensive documentation
- Analyze clinical data for accuracy, consistency, and compliance with protocols
- Coordinate with CROs, investigators, and sponsors to resolve protocol deviations
- Develop and maintain study-specific monitoring plans and risk-based strategies
- Mentor junior CRAs and conduct investigator training sessions
- Prepare regulatory submissions and audit readiness documentation
Qualifications
- Bachelor's degree in life sciences, nursing, or related field (Master's preferred)
- 5+ years of clinical research experience with Phase II-III trials
- Certified Clinical Research Associate (CCRA) certification required
- Proven expertise in EDC systems (e.g., Medidata Rave) and CTMS platforms
- Strong knowledge of 21 CFR Part 11, FDA regulations, and ICH guidelines
- Exceptional problem-solving skills and attention to detail
- Ability to travel up to 40% internationally