Job Description
Join BioPharm Innovations, a leader in groundbreaking pharmaceutical research, as we pioneer the next generation of life-saving therapies. Our Boston-based team is seeking a passionate Senior Clinical Research Associate to drive excellence in clinical trial execution. You'll collaborate with cross-functional teams to ensure studies meet regulatory standards while accelerating innovation in cardiovascular and oncology treatments.
We offer a dynamic environment where your expertise directly impacts patient outcomes. Enjoy competitive benefits, continuous learning opportunities, and the chance to shape the future of medicine at a company committed to scientific integrity and ethical excellence.
Responsibilities
- Design and execute clinical trial protocols ensuring compliance with FDA/ICH/GCP regulations
- Monitor investigative sites for protocol adherence, data integrity, and regulatory compliance
- Lead site initiation, interim monitoring, and closeout visits with flawless documentation
- Analyze clinical data to identify trends, risks, and optimization opportunities
- Mentor junior CRAs and collaborate with biostatistics, medical affairs, and regulatory teams
- Develop risk-based monitoring strategies and vendor management protocols
Qualifications
- Bachelor's degree in life sciences, pharmacy, or related field (Master's preferred)
- 5+ years of clinical research experience with 2+ in CRA roles
- Certified Clinical Research Professional (CCRP) or equivalent certification
- Proven expertise in oncology and cardiovascular therapeutic areas
- Exceptional knowledge of FDA 21 CFR Part 812 and ICH-GCP guidelines
- Advanced proficiency in eCRF systems (e.g., Medidata Rave, Veeva Vault)
- Strong analytical skills with attention to detail in complex data environments