Kerr Dental

Senior Clinical Research Associate

Kerr Dental

full-time

Posted on:

Origin:  • 🇺🇸 United States • California

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Salary

💰 $103,600 - $192,400 per year

Job Level

Senior

Tech Stack

Google Cloud Platform

About the role

  • Remote Based position; candidates must be located near an airport (West Coast highly desirable)
  • Senior CRA performs monitoring activities related to initiation, conduct and timely completion of Phase I-IV Pharma clinical trials within the country
  • Responsible for delivering data within timelines and required quality standard; adherence to ICH/GCP, US CFR and company SOPs
  • Up to 80% travel required
  • Serves as primary site manager and frontline liaison between Novartis and investigative sites
  • Manages assigned study sites/networks, conducts phase I-IV protocols according to monitoring plan and procedures
  • Prepares and collects site and country level documents; performs Site Initiation Visit and continuous training
  • Conducts onsite and/or remote monitoring; ensures compliance with protocol, GCP, global and local regulations
  • Updates relevant electronic systems; may act as SME as needed
  • Monitors studies per current legislations and Novartis standards; identifies, resolves & escalates issues
  • Collaborates with Clinical Project Manager, CRA Manager, MSL, CRMD, medical advisor and Strategic Site Partner

Requirements

  • BS/BA degree. Scientific or healthcare discipline preferred
  • Minimum of 3 years’ experience in site monitoring strongly preferred
  • RLT/CAR T experience a plus!
  • 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 (driving is an essential function)