Job Description
Join our cutting-edge pharmaceutical team at BioPharm Innovations Inc., a leader in developing transformative therapies for rare diseases. We seek a passionate Senior Clinical Research Associate to drive excellence in clinical trials across multiple therapeutic areas. This pivotal role offers the opportunity to shape the future of patient care while working with world-class scientists in our state-of-the-art Boston facilities. Enjoy competitive compensation, comprehensive benefits, and a culture that champions innovation and professional growth.
Responsibilities
- Design, implement, and monitor Phase I-IV clinical trials ensuring GCP/ICH compliance
- Lead site initiation, monitoring visits, and closeout activities across 5-8 global sites
- Collaborate with cross-functional teams (Regulatory, Medical, Biostatistics) on protocol development
- Manage clinical trial documentation and ensure FDA/EMA regulatory submissions
- Analyze safety data and escalate critical issues to senior leadership
- Mentor junior CRAs and conduct investigator training sessions
- Drive process improvements to enhance trial efficiency and patient recruitment
Qualifications
- Master's degree in Life Sciences, Pharmacy, or related field (PhD preferred)
- 5+ years of clinical research experience with 2+ years in CRA role
- ICH-GCP certification and documented FDA/EMA audit experience
- Proven track record in managing complex multi-site oncology/neurology trials
- Expertise in EDC systems (Medidata Rave, Oracle RDC) and CTMS platforms
- Strong knowledge of FDA 21 CFR Part 11 and clinical trial regulations
- Exceptional communication skills with fluency in English and Spanish
- Certified Clinical Research Associate (CCRA) credential