Job Description
Join our pioneering team at Novartis Pharmaceuticals as a Senior Clinical Research Associate in Boston. You'll be at the forefront of developing life-changing therapies while working in a collaborative, innovative environment. We offer competitive benefits, professional development opportunities, and the chance to contribute to breakthrough medical advancements.
Responsibilities
- Monitor clinical trial sites to ensure protocol compliance and regulatory adherence
- Coordinate site initiation, interim monitoring, and closeout visits
- Manage clinical trial documentation and source data verification
- Liaise with investigators, sponsors, and regulatory authorities
- Lead risk-based monitoring strategies and data quality assessments
- Mentor junior CRAs and contribute to process improvements
- Prepare regulatory submissions and audit readiness documentation
Qualifications
- Bachelor's degree in life sciences, pharmacy, or related field (Master's preferred)
- 3+ years of clinical research experience in pharmaceutical/biotech
- Certified Clinical Research Associate (CCRA) certification
- Thorough knowledge of ICH-GCP and FDA regulations
- Strong site management and vendor management experience
- Exceptional communication and problem-solving skills
- Ability to travel up to 40% of the time
- Experience with EDC systems (e.g., Medidata Rave) preferred