Job Description
Join BioPharm Innovations Inc., a leader in cutting-edge pharmaceutical research, as we pioneer next-generation therapies. We seek a dynamic Senior Clinical Research Associate to drive excellence in clinical trial execution and regulatory compliance. This pivotal role offers the opportunity to shape the future of medicine while collaborating with world-class scientists and regulatory experts.
Our Boston-based R&D hub combines state-of-the-art facilities with a culture of scientific rigor and innovation. As a member of our clinical operations team, you'll contribute to groundbreaking treatments that transform patient lives while advancing your career in one of the world's most impactful industries.
Responsibilities
- Lead site monitoring activities for Phase II-III clinical trials ensuring GCP compliance
- Oversee clinical trial protocol implementation and investigator training
- Manage regulatory documentation submissions to FDA and international authorities
- Analyze clinical data integrity and resolve protocol deviations
- Coordinate cross-functional teams to meet critical trial milestones
- Develop risk-based monitoring strategies for complex therapeutic areas
- Maintain real-time trial status dashboards for leadership review
Qualifications
- Bachelor's degree in Pharmacy, Life Sciences, or related field (Master's preferred)
- 5+ years clinical research experience with 2+ years in CRA role
- Certified Clinical Research Associate (CCRA) certification required
- Expert knowledge of ICH-GCP, FDA regulations, and ISO standards
- Proven experience monitoring oncology/neurology therapeutic areas
- Advanced proficiency in EDC systems (Medidata Rave, Veeva Vault)
- Exceptional problem-solving and stakeholder management skills