Job Description
Join our pioneering team at BioPharm Innovations, a leader in next-generation therapeutics. We're seeking a dedicated Senior Clinical Research Associate to drive our Phase II-III oncology trials forward. You'll collaborate with cross-functional teams to ensure protocol compliance, data integrity, and regulatory excellence while making tangible impacts in patient care. Our Boston hub offers cutting-edge labs, competitive benefits, and a culture of scientific curiosity.
Responsibilities
- Design and execute clinical trial protocols in compliance with FDA/ICH-GCP standards
- Monitor investigational sites for protocol adherence and data quality
- Manage site relationships and provide expert training on clinical procedures
- Analyze adverse events and safety data for regulatory reporting
- Coordinate with CROs and vendors for trial logistics and vendor management
- Maintain electronic trial master files (eTMF) and regulatory documentation
- Lead cross-functional meetings for trial progress and risk mitigation
Qualifications
- Master's degree in Life Sciences, Pharmacy, or related field
- 5+ years clinical research experience in oncology trials
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Proven expertise in EDC systems (e.g., Medidata Rave) and TMF management
- Deep knowledge of FDA/EMA regulations and ICH-GCP guidelines
- Exceptional data management and statistical analysis skills
- Strong site management and vendor relationship capabilities
- Experience with risk-based monitoring (RBM) methodologies