Senior Clinical Research Associate

Role Overview

• Serves as the primary site manager for assigned clinical investigative sites (first point of contact between investigative site staff and Novartis)
• Is the frontline liaison between Novartis and sites to ensure successful collaboration, meeting Novartis expectation on milestone and deliveries
• Manages assigned study sites/networks, conducting phase I-IV protocols according to the monitoring plan and Novartis procedures
• Facilitates the preparation and collection of site and country level documents
• Performs Site Initiation Visit, ensures site personnel are fully trained on all trial related aspects and performs continuous training for amendments and new site personnel as required.
• Conducts continuous monitoring activities (onsite and/or remote). Implements site management activities to ensure compliance with protocol, GCP, global and local regulations, global and local processes to secure data integrity and patient safety.
• Accountable for continuously updating all relevant electronic systems to perform job functions
• Takes on the responsibility as SME (Subject Matter Expert) as needed
• Monitors studies as per current legislations, ICH/GCP and Novartis standards
• Ensures timely delivery, of high quality, robust and reliable data of the monitored sites to support the goals of Trial Monitoring as defined by Trial Monitoring.
• Identifies, resolves & escalates issues appropriately
• Collaborates with internal stakeholders and site personnel to manage data query resolution process to ensure timely and accurate data entry
• Proactively collaborates with the Clinical Project Manager (CPM) and CRA Manager as well as Medical Scientific Liaison (MSL), Clinical Regional Medical Director (CRMD), medical advisor and Strategic Site Partner to achieve key accountabilities
• Partners with SSU CRA to ensure seamless transition of site responsibility

Requirements

• 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
• Minimum of 3 years’ experience in site monitoring strongly preferred
• RLT, CAR T or Oncology experience a plus!

Tech Stack

• Google Cloud Platform

Benefits

• Health insurance
• 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