Job Description
Join BioPharm Innovations Inc. at the forefront of medical breakthroughs as a Senior Clinical Research Associate. We're seeking a passionate professional to drive excellence in clinical trials, ensuring regulatory compliance while advancing life-changing therapies. Collaborate with cross-functional teams to design, execute, and monitor studies that shape the future of healthcare. Enjoy a competitive compensation package, comprehensive benefits, and opportunities for professional growth in a dynamic, research-driven environment.
Responsibilities
- Design and implement clinical trial protocols ensuring alignment with FDA/ICH guidelines
- Monitor site performance, conduct site visits, and ensure GCP compliance
- Manage clinical documentation, including CRFs, AE reports, and regulatory submissions
- Analyze trial data and prepare comprehensive study reports for stakeholders
- Liaise with investigators, sponsors, and regulatory authorities to resolve issues
- Mentor junior CRAs and contribute to process improvements
Qualifications
- Bachelor's degree in life sciences, pharmacy, or related field (Master's preferred)
- 5+ years of clinical research experience with 2+ years in CRA roles
- Certified Clinical Research Associate (CCRA) or equivalent certification
- Expertise in FDA/ICH-GCP, FDA 21 CFR Part 820, and clinical trial regulations
- Strong proficiency in EDC systems (e.g., Medidata Rave) and risk-based monitoring
- Exceptional communication skills and ability to manage multiple stakeholders
- Proven track record in oncology or rare disease trials preferred