Job Description
Join BioPharm Innovations at the forefront of medical breakthroughs as a Senior Clinical Research Associate. We're seeking a dedicated professional to drive excellence in clinical trials, ensuring regulatory compliance and patient safety while accelerating the development of life-changing therapies. Our Cambridge headquarters offers state-of-the-art labs and a collaborative environment where your expertise directly impacts global healthcare.
Responsibilities
- Design, implement, and monitor Phase I-IV clinical trials across multiple therapeutic areas
- Ensure protocol adherence and GCP compliance through site monitoring, audits, and vendor oversight
- Lead cross-functional teams including physicians, biostatisticians, and regulatory affairs specialists
- Analyze clinical data and prepare regulatory submissions (IND/CTD) for FDA/EMA approval
- Develop risk-based monitoring strategies and implement eClinical systems (Medidata Rave, Veeva Vault)
- Mentor junior CRAs and optimize clinical trial processes through continuous improvement
Qualifications
- Master's degree in Life Sciences, Pharmacy, or related field (PhD preferred)
- 5+ years of clinical research experience with 2+ years in CRA/clinical operations
- Certified Clinical Research Associate (ACRP/SoCRA) certification required
- Proven expertise in FDA/EMA regulations, GCP, and ICH guidelines
- Strong proficiency in EDC systems and clinical trial management software
- Exceptional communication skills with ability to lead stakeholder negotiations
- Experience managing oncology or rare disease trials highly desirable