Novartis is hiring a Clinical Research Associate/Senior Clinical Research Associate to join a team dedicated to advancing medicine through clinical trials. This is a remote position that requires up to 80% travel to manage investigative sites and ensure the timely delivery of high-quality data for Phase I-IV Pharma clinical trials.
What You'll Do
- Serve as the primary site manager and first point of contact for assigned clinical investigative sites.
- Manage assigned study sites/networks, conducting Phase I-IV protocols according to the monitoring plan and company procedures.
- Facilitate the preparation and collection of site and country level documents.
- Perform Site Initiation Visits and ensure site personnel are fully trained on trial-related aspects.
- Conduct continuous monitoring activities (onsite and/or remote) to ensure compliance with protocol, GCP, and regulations.
- Continuously update all relevant electronic systems.
- Monitor studies as per current legislations, ICH/GCP, and company standards.
- 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.
- Fluent in both written and spoken English.
- Fully valid and unrestricted driver’s license.
Nice to Have
- Scientific or healthcare discipline.
- Minimum of 3 years’ experience in site monitoring strongly preferred for Senior level.
- Previous CRA experience required for Senior level.
- 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).
Technical Stack
- Clinical Trial Management Systems
Team & Environment
You will collaborate with a group of internal stakeholders including the Clinical Project Manager (CPM), CRA Manager, Medical Scientific Liaison (MSL), Clinical Regional Medical Director (CRMD), medical advisor, and Strategic Site Partner.
Benefits & Compensation
- Compensation: $103,600 - $192,400 per year + equity eligibility.
- Health, life and disability benefits.
- 401(k) with company contribution and match.
- Generous time off package including vacation, personal days, holidays and other leaves.
- Performance-based cash incentive.
- Eligibility to be considered for annual equity awards.
Work Mode
This is a remote position based in the U.S. You must be located near an airport. Residency in Louisiana, Arkansas, Alabama, or Mississippi 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, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
