Job Description
Join BioPharm Innovations as a Senior Clinical Research Associate and lead groundbreaking trials that shape the future of medicine. We're seeking a dedicated professional to oversee complex clinical studies, ensuring compliance with FDA regulations and GCP standards. You'll collaborate with cross-functional teams to drive protocol development, site monitoring, and data integrity initiatives. This role offers the opportunity to work on cutting-edge therapeutics while advancing your career in a dynamic, mission-driven environment.
Responsibilities
- Design and execute clinical trial protocols for Phase I-III studies
- Monitor investigational sites for regulatory compliance and protocol adherence
- Manage vendor relationships and CRO partnerships for trial execution
- Analyze clinical data and prepare regulatory submissions (IND/CTA)
- Mentor junior CRAs and optimize clinical trial workflows
- Represent company at FDA audits and health authority inspections
Qualifications
- Master's degree in Life Sciences, Pharmacy, or related field
- 5+ years of clinical research experience in pharma/biotech
- Certified Clinical Research Associate (CCRA) certification required
- Expertise in ICH-GCP, FDA 21 CFR Part 820, and ISO 14155
- Proven track record in managing multi-center oncology trials
- Advanced proficiency in Medidata Rave and CTMS systems
- Strong problem-solving skills for protocol deviation resolution