Job Description
Join BioPharm Innovations at the forefront of medical breakthroughs as a Senior Clinical Research Associate. Lead pivotal clinical trials that transform patient outcomes while working in our state-of-the-art Cambridge facility. Collaborate with cross-functional teams to ensure protocol integrity, regulatory compliance, and data excellence in our mission to deliver innovative therapies.
Responsibilities
- Design and execute clinical trial protocols with GCP/ICH compliance
- Monitor investigational sites for protocol adherence and data integrity
- Manage vendor relationships and CRO partnerships
- Analyze clinical data and prepare regulatory submissions
- Mentor junior CRAs and optimize trial workflows
- Lead site initiation, monitoring, and closeout activities
Qualifications
- BS/MS in Life Sciences, Pharmacy, or related field
- 5+ years clinical research experience in pharma/biotech
- CRA certification (ACRP or SOCRA)
- Deep knowledge of FDA/EMA regulations and ICH-GCP
- Experience with EDC systems (e.g., Medidata Rave)
- Proven site management and audit skills
- Strong written/verbal communication abilities