Job Description
Join BioPharm Innovations as a Senior Clinical Research Associate and drive breakthroughs in pharmaceutical development. We're seeking a passionate professional to oversee critical clinical trials, ensuring regulatory compliance and data integrity while collaborating with cross-functional teams to accelerate life-changing therapies. This role offers unparalleled growth in Boston's premier biotech hub.
Responsibilities
- Design and execute clinical trial protocols in compliance with FDA/ICH guidelines
- Monitor investigational sites for protocol adherence and data quality
- Lead site selection, initiation, and closure processes
- Analyze clinical data and prepare regulatory submissions
- Coordinate with CROs, sponsors, and ethics committees
- Mentor junior associates and optimize trial workflows
Qualifications
- BS/MS in Pharmacy, Biology, or related field (PhD preferred)
- 5+ years of clinical research experience in pharma/biotech
- ICH-GCP certification and FDA/EMA regulatory knowledge
- Proven track record of managing Phase II-III trials
- Exceptional data management and audit skills
- Strong leadership and cross-functional collaboration abilities