Novartis is hiring a Senior Clinical Research Associate to perform monitoring activities for Phase I-IV pharmaceutical clinical trials. In this remote position, you will be responsible for delivering high-quality data within established timelines and ensuring adherence to ICH/GCP, US CFR, and company SOPs.
What You'll Do
- Serve as the primary site manager and first point of contact for assigned clinical investigative sites.
- Act as the frontline liaison between Novartis and sites to ensure successful collaboration and meeting of milestones.
- Manage assigned study sites/networks, conducting phase I-IV protocols according to the monitoring plan and Novartis procedures.
- Facilitate the preparation and collection of site and country level documents.
- Perform Site Initiation Visits and ensure site personnel are fully trained on all trial-related aspects.
- Conduct continuous monitoring activities (onsite and/or remote) to ensure compliance with protocol, GCP, and regulations.
- Implement site management activities to secure data integrity and patient safety.
- Continuously update all relevant electronic systems to perform job functions.
- Act as a Subject Matter Expert (SME) as needed.
- Monitor studies as per current legislations, ICH/GCP and Novartis standards.
- Ensure timely delivery of high quality, robust and reliable data from monitored sites.
- Identify, resolve, and escalate issues appropriately.
- Collaborate with internal stakeholders and site personnel to manage the data query resolution process.
- Proactively collaborate with the Clinical Project Manager (CPM), CRA Manager, Medical Scientific Liaison (MSL), Clinical Regional Medical Director (CRMD), medical advisor, and Strategic Site Partner.
- Partner with SSU CRA to ensure seamless transition of site responsibility.
What We're Looking For
- BS/BA degree.
- 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.
- Fully valid and unrestricted driver’s license (driving is an Essential Function of this Role).
Nice to Have
- Scientific or healthcare discipline preferred.
- Minimum of 3 years’ experience in site monitoring strongly preferred.
- Oncology, Neuroscience monitoring experience highly desirable.
- CAR T and/or RLT experience a plus.
Team & Environment
You will collaborate closely with the Clinical Project Manager (CPM), CRA Manager, Medical Scientific Liaison (MSL), Clinical Regional Medical Director (CRMD), medical advisor, Strategic Site Partner, and SSU CRA.
Benefits & Compensation
- Compensation: $103,600 - $192,400 per year + equity: Eligibility to be considered for annual equity awards.
- Performance-based cash incentive.
- Comprehensive benefits package including health, life and disability benefits.
- 401(k) with company contribution and match.
- Generous time off package including vacation, personal days, holidays and other leaves.
Work Mode
This is a fully remote position based in the U.S. Candidates must be located near an airport; a Northeast location is highly desirable.
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
