Job Description
Join BioPharm Innovations Inc., a leader in cutting-edge pharmaceutical research, as we pioneer the next generation of life-changing therapies. We're seeking a dynamic Senior Clinical Research Associate to oversee critical Phase II-III clinical trials with a focus on oncology and immunology. This hybrid role offers the opportunity to work alongside world-class scientists while maintaining flexibility to balance professional excellence with personal well-being.
Responsibilities
- Design, implement, and monitor global clinical trial protocols ensuring GCP/ICH compliance
- Lead site initiation, monitoring, and closure activities for 8-10 investigational sites
- Manage clinical trial documentation including CRFs, IBs, and regulatory submissions
- Analyze and interpret complex safety/efficacy data for FDA/EMA reporting
- Collaborate with cross-functional teams (Biostatistics, Medical Affairs, Data Management)
- Mentor junior CRAs and optimize clinical trial operational workflows
Qualifications
- BS/MS in Life Sciences, Pharmacy, or related field with 5+ years clinical trial experience
- Certified CRA (ACRP or SoCRA) required
- Proven expertise in oncology/immunology therapeutic areas
- Strong proficiency in EDC systems (e.g., Medidata Rave, Veeva Vault)
- Exceptional audit management and risk-based monitoring skills
- Excellent communication with ability to present to regulatory authorities
- Willingness to travel up to 30% domestically