Clinical Research Associate II - Remote

Overview

As a Clinical Research Associate at PSI you will enjoy a variety of monitoring tasks and work on clinical studies in different therapeutic indications, maintaining the highest quality standards in the industry.

In Short

• Act as the main line of communication between the project team, sponsor, and the site
• Build and maintain a good relationship with the site staff involved in the study conduct
• Prepare, conduct, and report site selection, initiation, routine monitoring and close-out visits
• Ensure that subject recruitment targets are timely defined, communicated, recorded and met
• Perform source data verification and follow up on data queries at site level
• Ensure proper handling and accountability of all Investigational Product(s)
• Conduct site audit preparation visits and resolve site audit findings
• Support preparation of draft regulatory and ethics committee submission packages
• Facilitate review and reconciliation of the study TMF on country and site levels
• Support collection of IP-RED packages at site/country level

Requirements

• College/University degree in Life Sciences or equivalent
• 2+ years of independent on-site monitoring experience
• Experience in all types of monitoring visits, in phases I-III
• Experience in Oncology and GI/GU highly preferred
• Full working proficiency in English
• Proficiency in MS Office applications
• Ability to plan, multitask and work in a dynamic team environment
• Communication, collaboration, and problem-solving skills
• Ability to travel up to 75%
• Valid driver’s license (if applicable)

Benefits

• Opportunity to further develop skills
• Widen therapeutic area experience
• Become an expert in clinical research