Clinical Research Associate II – Oncology

Role Overview

• Considered as the primary point of contact for the investigative site
• Conducts site evaluation, site training, routine, and site closure monitoring activities
• Aligns, trains and motivates the site staff and principal investigator
• Develop solid knowledge of therapeutic area, asset and clinical landscape / patient journey
• Ensures quality of data submitted from study sites
• Protect study subjects' safety
• Manages investigator payments as per executed contract obligations

Requirements

• Minimum of 1 year of clinically related experience
• 6 months required in clinical research monitoring of investigational drug or device trials
• Familiar with risk‐based monitoring approach
• Knowledge of appropriate therapeutic area indications is preferred
• Advanced knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies
• Strong cross-functional collaboration skills among internal and external stakeholders
• Advanced ability to leverage technology, tools and resources

Tech Stack

• Google Cloud Platform

Benefits

• medical/dental/vision insurance
• 401(k) to eligible employees
• paid time off (vacation, holidays, sick)
• participate in short-term incentive programs