Job Description
Join BioPharm Innovations as a Senior Clinical Research Associate and lead groundbreaking pharmaceutical trials in our state-of-the-art Cambridge facility. We're seeking a dedicated professional to drive clinical excellence and accelerate drug development while ensuring compliance with FDA and ICH-GCP standards. This role offers unparalleled opportunities to shape the future of medicine in a collaborative, innovation-driven environment.
Responsibilities
- Design and execute clinical trial protocols across Phase I-III studies
- Monitor investigational sites to ensure protocol adherence and data integrity
- Manage clinical documentation and regulatory submissions
- Collaborate with cross-functional teams (MDs, statisticians, regulatory affairs)
- Analyze safety data and prepare regulatory reports
- Mentor junior CRAs and implement process improvements
Qualifications
- Master's degree in Pharmacy, Life Sciences, or related field
- 5+ years clinical research experience in pharmaceutical/biotech
- Certified Clinical Research Associate (CCRA) or equivalent certification
- Deep knowledge of ICH-GCP and FDA regulations
- Experience with EDC systems (e.g., Medidata Rave)
- Strong project management and problem-solving skills
- Excellent written/verbal communication abilities