Job Description
Join BioPharm Innovations Inc., a leader in cutting-edge pharmaceutical research, as we pioneer the next generation of life-changing therapies. Our Boston-based team is seeking a dynamic Senior Clinical Research Associate to drive critical clinical trial operations. You'll collaborate with cross-functional teams to ensure regulatory compliance, data integrity, and seamless trial execution across Phase II-III studies. This role offers competitive compensation, comprehensive benefits, and the opportunity to impact global healthcare innovation.
Responsibilities
- Oversee clinical trial execution and site monitoring for assigned studies
- Ensure compliance with FDA regulations, ICH-GCP, and protocol requirements
- Manage investigator relationships and site selection processes
- Analyze clinical data and prepare regulatory documentation
- Lead cross-functional teams to resolve trial-related issues
- Maintain accurate trial documentation and electronic data capture systems
- Conduct site visits and audits to verify protocol adherence
Qualifications
- Bachelor's degree in Pharmacy, Nursing, or Life Sciences (Master's preferred)
- 5+ years of clinical research experience with Phase II-III trials
- Certified Clinical Research Associate (CCRA) or equivalent certification
- Strong knowledge of FDA regulations and GCP principles
- Experience with EDC systems (e.g., Medidata Rave) and CTMS
- Exceptional problem-solving and communication skills
- Ability to travel 25-30% domestically/internationally