Job Description
Join BioPharm Innovations as a Senior Clinical Research Associate and drive groundbreaking advancements in pharmaceutical research. We're seeking a dedicated professional to oversee complex clinical trials, ensuring compliance with FDA regulations and GCP standards. This role offers the opportunity to collaborate with leading scientists and contribute to life-changing therapies while advancing your career in one of the world's most innovative biotech hubs.
Our Cambridge-based team operates at the intersection of cutting-edge science and regulatory excellence. As a key member of our clinical operations division, you'll play a pivotal role in bringing novel treatments from laboratory to market, directly impacting patient outcomes and healthcare innovation.
Responsibilities
- Design and implement comprehensive clinical trial protocols in compliance with FDA regulations and ICH-GCP guidelines
- Monitor site activities, including source data verification and audit preparation, to ensure trial integrity
- Lead cross-functional teams of CRA, biostatisticians, and medical writers to drive trial execution
- Manage investigational product accountability and adverse event reporting systems
- Develop risk-based monitoring strategies and vendor management protocols
- Prepare regulatory submissions and interact with FDA/EMA authorities during inspections
- Mentor junior CRAs and contribute to continuous process improvement initiatives
Qualifications
- Bachelor's degree in life sciences, pharmacy, or related field (Master's preferred)
- 5+ years of clinical research experience with at least 2 years in CRA roles
- Certified Clinical Research Professional (CCRP) or equivalent certification required
- Demonstrated expertise in Phase II-III clinical trial management across therapeutic areas
- Proficiency in eCRF systems (e.g., Medidata Rave, Veeva Vault RIM)
- Strong knowledge of 21 CFR Part 312/820 and international regulatory standards
- Exceptional problem-solving skills and ability to manage complex trial logistics
- Experience with site initiation, monitoring, and closeout activities