Job Description
Join BioInnovate Therapeutics, a leader in oncology drug development, as we pioneer next-generation immunotherapies. We're seeking a meticulous Senior Clinical Research Associate to oversee pivotal clinical trials across multiple sites. In this role, you'll ensure protocol compliance, manage site relationships, and drive data integrity while collaborating with cross-functional teams. Our Cambridge headquarters offers cutting-edge labs and a dynamic, mission-driven environment.
Responsibilities
- Monitor clinical trial sites for protocol adherence and regulatory compliance (GCP/ICH)
- Conduct site initiation, monitoring, and closeout visits with detailed documentation
- Collaborate with CROs, investigators, and internal stakeholders to resolve site issues
- Analyze clinical data for accuracy and consistency, preparing audit-ready reports
- Maintain up-to-date trial documentation in electronic systems (e.g., Medidata Rave)
- Train site staff on trial procedures and regulatory requirements
- Represent BioInnovate at investigator meetings and regulatory inspections
Qualifications
- Bachelor's degree in life sciences, nursing, or related field (MS/PhD preferred)
- 5+ years of clinical research experience with oncology trials
- Certified Clinical Research Associate (CCRA) or equivalent certification
- Proven expertise in FDA/EMA regulations and ICH-GCP guidelines
- Strong proficiency in EDC systems and clinical trial management tools
- Exceptional attention to detail and problem-solving abilities
- Ability to travel 30-40% domestically and internationally