Job Description
Join BioPharm Innovations Inc., a global leader in biopharmaceutical research, as we pioneer next-generation therapies for rare diseases. Our Cambridge, MA headquarters sits at the heart of the world's most dynamic life sciences ecosystem. As a Senior Clinical Research Associate, you'll drive pivotal clinical trials that transform patient outcomes while collaborating with Nobel laureates and industry pioneers. We offer competitive compensation, comprehensive benefits, and a culture where scientific curiosity fuels breakthroughs.
Responsibilities
- Lead end-to-end clinical trial execution across Phase II-III studies
- Monitor 15+ investigative sites for protocol compliance and data integrity
- Develop risk-based monitoring strategies using eClinical platforms
- Collaborate with cross-functional teams (Regulatory, Medical Affairs, Biostatistics)
- Author critical trial documentation (IBs, protocols, reports)
- Mentor junior CRAs and conduct site initiation visits
- Ensure GCP/ICH/FDA compliance throughout trial lifecycle
Qualifications
- MS/PhD in life sciences or related field with 5+ years clinical research experience
- CRA certification (ACRP/SoCRA) required
- Proven expertise in oncology or rare disease trials
- Advanced proficiency in Medidata Rave and Veeva Vault
- Strong track record in FDA audit readiness
- Excellent written/verbal communication skills
- Ability to travel 30-40% domestically/internationally
- Experience with decentralized clinical trials preferred