Job Description
Join Novartis Pharmaceuticals as a Clinical Research Associate and become a pivotal force in advancing healthcare innovation. Based in our Cambridge, MA hub, you'll orchestrate pivotal clinical trials that shape the future of medicine. This role offers unparalleled exposure to cutting-edge therapies and global regulatory landscapes, with comprehensive benefits including relocation assistance and continuing education stipends.
Responsibilities
- Oversee site management and trial execution across 3-5 clinical sites
- Ensure protocol compliance and FDA/ICH-GCP adherence through meticulous monitoring
- Lead vendor management and budget oversight for assigned studies
- Collaborate with cross-functional teams (medical, regulatory, biostatistics)
- Generate comprehensive monitoring reports and risk assessments
- Mentor junior CRAs and contribute to process optimization
Qualifications
- Bachelor's degree in life sciences, nursing, or related field (MS/PhD preferred)
- 3+ years of clinical monitoring experience in therapeutic areas (oncology/cardiometabolic preferred)
- Certified Clinical Research Associate (CCRA) or equivalent certification
- Proven expertise in EDC systems (Medidata Rave) and risk-based monitoring
- Exceptional audit management and regulatory documentation skills
- Strong problem-solving abilities with complex site interactions