Senior Clinical Research Associate
Job Description Summary
Key responsibilities
- Primary site manager and first point of contact between site staff and Novartis
- Frontline liaison supporting collaboration, milestones, and deliverables
- Monitor according to legislation, ICH/GCP, and Novartis standards
- Manage assigned sites/networks conducting Phase I-IV protocols according to monitoring plans and Novartis procedures
- Conduct site initiation visits and deliver ongoing training for site personnel
- Continuous on-site/remote monitoring; protocol, GCP, regulatory and process compliance; data integrity and patient safety
- Facilitate preparation and collection of site- and country-level documents
- Identify risks, resolve issues, and escalate concerns as needed
- Collaborate with cross-functional teams to drive efficient study execution
- Deliver timely, high-quality, robust, reliable site data supporting Trial Monitoring goals
- Partner with SSU CRA for seamless transition of site responsibility
- Act as a subject matter expert across study activities when required
Essential Requirements:
- Minimum of 3 years' experience in site monitoring
- BS/BA degree. Scientific, Healthcare or other related field.
- Excellent knowledge of the drug development process specifically clinical trial/research
- Knowledge of international standards (GCP/ICH, FDA, EMEA)
- Ability to manage multiple priorities and manage time efficiently.
- Excellent Site management capabilities with demonstrated negotiating and problem-solving skills
- Strong communicator and presentation skills (oral and written)
- Fluent in both written and spoken English
Desirable Requirements :
- Cardiology, Oncology, CART, RLT & Immunology experience a plus!
The salary for this position is expected to range between $108,500 and $201,500 per year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
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Driving and air travel are an Essential Function of this Role
COVID-19 Vaccine Policy
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Skills
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