Job Description
Join BioPharm Innovations, a global leader in biopharmaceutical research, as we pioneer next-generation therapies for unmet medical needs. We seek a dynamic Senior Clinical Research Associate to drive excellence in clinical trial execution across our oncology portfolio. This pivotal role combines scientific rigor with operational leadership to accelerate life-changing treatments from lab to patient.
As a cornerstone of our Clinical Operations team, you'll shape the future of medicine by ensuring trial integrity, regulatory compliance, and seamless site collaboration. Our Boston hub offers unparalleled access to academic institutions, cutting-edge labs, and a vibrant biotech ecosystem. Enjoy competitive compensation, comprehensive benefits, and opportunities for professional growth in one of healthcare's most critical fields.
Responsibilities
- Oversee clinical trial conduct at 3-5 investigational sites, ensuring protocol adherence and GCP compliance
- Lead site initiation, monitoring, and closeout activities with 100% audit-ready documentation
- Collaborate with cross-functional teams (Medical, Regulatory, Data Management) to resolve protocol deviations
- Develop risk-based monitoring strategies and vendor management protocols
- Mentor junior CRAs and contribute to SOP development for clinical operations
- Analyze trial data trends and provide actionable insights to study leadership
- Represent BioPharm at investigator meetings and regulatory agency interactions
Qualifications
- Bachelor's degree in life sciences, nursing, or related field; Master's or PhD preferred
- 5+ years of clinical research experience with 2+ years in CRA role
- Certified Clinical Research Associate (CCRA) or SOCRA certification required
- Expertise in oncology trials and experience with Phase I-III studies
- Proficiency in EDC systems (e.g., Medidata Rave, Veeva Vault)
- Demonstrated success in site management and conflict resolution
- Strong knowledge of ICH-GCP, FDA regulations, and international guidelines
- Ability to travel domestically 30-40% of time