Job Description
Join BioGenix Pharmaceuticals, a global leader in innovative therapeutics, as we pioneer the next generation of life-changing treatments. We seek a dynamic Senior Clinical Research Associate to spearhead clinical trial operations across our oncology portfolio. This pivotal role combines scientific rigor with strategic site management, ensuring our trials deliver transformative results while maintaining uncompromising regulatory compliance.
Our Boston hub sits at the intersection of academia and industry, offering unparalleled access to world-class medical institutions and cutting-edge research facilities. You'll collaborate with multidisciplinary teams spanning biostatistics, data science, and regulatory affairs to shape the future of precision medicine.
Responsibilities
- Oversee clinical trial execution across 15+ investigational sites, ensuring protocol adherence and GCP compliance
- Conduct comprehensive site monitoring visits, source data verification, and vendor management
- Lead risk-based monitoring strategies and implement quality management systems
- Collaborate with cross-functional teams to develop trial protocols and CRFs
- Manage regulatory documentation (INDs, IRB submissions) and adverse event reporting
- Mentor junior CRAs and contribute to process optimization initiatives
Qualifications
- Master's degree in life sciences, pharmacy, or related field with 5+ years clinical research experience
- Certified CRA (CCRA) or equivalent certification strongly preferred
- Proven expertise in oncology therapeutic area and complex trial designs
- Advanced proficiency in EDC systems (e.g., Medidata Rave) and TMF management
- Demonstrated success in FDA/EMA regulatory inspections and audit readiness
- Exceptional communication skills with international site management experience