Senior Clinical Research Associate
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Job Description
Senior Clinical Research Associate advancing Novartis Phase I–IV clinical trials through site monitoring. Managing investigator relationships, compliance, patient safety, and reliable trial data across the U.S.
Responsibilities:
- Manage trusted site relationships and perform on-site and remote monitoring activities for Phase I–IV clinical trials
- Support trial initiation, conduct, and timely completion in compliance with ICH/GCP, local regulations, SOPs, and monitoring procedures
- Serve as the primary site manager and first point of contact between site staff and Novartis
- Support collaboration, milestones, and deliverables as a frontline liaison
- Manage assigned sites and networks according to monitoring plans and Novartis procedures
- Conduct site initiation visits and provide ongoing training for site personnel
- Perform continuous on-site and remote monitoring for 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 and process improvements
- 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
- Support audit and inspection readiness activities and corrective action implementation
Requirements:
- Minimum of 3 years’ experience in site monitoring
- BS/BA degree in Scientific, Healthcare or 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
- Must have a fully valid and unrestricted driver’s license
- Willingness and ability to travel by plane or car up to 80% of the time
- RLT, CAR T or Oncology experience a plus
Benefits:
- Performance-based cash incentive
- Eligibility to be considered for annual equity awards, depending on role level
- Health benefits
- Life benefits
- Disability benefits
- 401(k) with company contribution and match
- Vacation
- Personal days
- Holidays
- Other leaves
- Reasonable accommodations for qualified individuals with disabilities
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