Job Description
Join BioPharm Innovations, a global leader in pharmaceutical research, as we pioneer breakthrough therapies for unmet medical needs. We seek a dynamic Senior Clinical Research Associate to drive excellence in clinical trials across our Boston headquarters. This pivotal role offers the opportunity to shape the future of medicine while collaborating with world-class scientists and regulatory experts. Enjoy competitive compensation, comprehensive benefits, and a culture that values innovation and professional growth.
Responsibilities
- Design and execute Phase I-IV clinical trials ensuring GCP compliance and protocol adherence
- Monitor investigational sites to maintain data integrity and regulatory standards
- Liaise with FDA, EMA, and global health authorities for regulatory submissions
- Lead cross-functional teams including biostatisticians, medical writers, and data managers
- Develop risk-based monitoring strategies and site management plans
- Analyze clinical data and prepare regulatory documentation for agency submissions
- Mentor junior CRAs and contribute to process improvement initiatives
Qualifications
- Master's degree in life sciences, pharmacy, or related field with 5+ years clinical research experience
- Certified CRA (CCRA) or equivalent certification required
- Proven track record in managing global Phase II-III trials across therapeutic areas
- Expert knowledge of ICH-GCP, FDA 21 CFR Part 312, and EU Clinical Trial Directive
- Strong proficiency in EDC systems (e.g., Medidata Rave, Veeva Vault)
- Exceptional communication skills with stakeholders across 15+ countries
- Experience in preparing FDA/EMA responses and audit readiness documentation