Research Analyst, Creative Excellence
Ipsos North America
Senior Clinical Research Associate
Kerr Dental
full-time
Posted on:
Location: California • 🇺🇸 United States
Visit company websiteSalary
💰 $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)
