Job Description
Join BioGenix Pharmaceuticals, a global leader in innovative drug discovery, as a Senior Clinical Research Associate. Shape the future of medicine by managing pivotal clinical trials that transform patient outcomes. Our Boston hub offers cutting-edge labs and collaborative teams dedicated to accelerating therapeutic breakthroughs. This role combines scientific rigor with strategic oversight to ensure regulatory compliance and data integrity across multi-center studies.
As a key member of our Clinical Operations team, you'll drive protocol execution, mentor junior associates, and interface with regulatory bodies. Our commitment to professional development includes continuous training on GCP guidelines and emerging technologies. Enjoy competitive benefits, flexible work arrangements, and the opportunity to contribute to therapies impacting millions of lives.
Responsibilities
- Oversee clinical trial execution across 5-10 sites ensuring adherence to FDA/ICH-GCP standards
- Lead site initiation, monitoring, and closure activities with 95%+ audit readiness
- Manage complex adverse events and safety reporting per 21 CFR Part 812 guidelines
- Collaborate with Biostatistics and Data Management teams to resolve protocol deviations
- Develop risk-based monitoring strategies and site training materials
- Represent BioGenix at FDA inspections and ethics committee submissions
- Mentor junior CRAs and optimize clinical trial workflows
Qualifications
- Bachelor's in Life Sciences, Nursing, or PharmD with 5+ years clinical research experience
- SOCRA or ACRP certification required (CCRP preferred)
- Proven track record in Phase II-III oncology/neurology trials
- Expertise in EDC systems (e.g., Medidata Rave) and CTMS platforms
- Deep understanding of 21 CFR Part 312 and ICH E6(R2) guidelines
- Exceptional cross-functional communication and stakeholder management
- Ability to travel 30% domestically/internationally
- Experience with eSource and risk-based monitoring methodologies