Performs monitoring activities related to initiation, conduct (recruitment, quality data collection) and timely completion of Phase I-IV Pharma clinical trials
Serves as the primary site manager for assigned clinical investigative sites
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
Conducts continuous monitoring activities (onsite and/or remote)
Accountable for continuously updating all relevant electronic systems to perform job functions
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

BS/BA degree in 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!

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

Senior Clinical Research Associate

Key skills