COA/eCOA Specialist

PSI CRO

2d•Onsite

About The Position

In this role, you will be responsible for managing and optimizing COA/eCOA systems for clinical trials. Your expertise will be vital in ensuring their smooth integration and effective implementation, which will be key to the success of our projects. Full-time employment based in Spain

Requirements

College/University degree
Prior industry experience in clinical research
Advanced proficiency in MS Office applications
Full working proficiency in English
Excellent communication and time management abilities, with a strong desire to learn and a curious mindset

Nice To Haves

Experience of working with clinical data systems and COA/eCOA systems is a plus

Responsibilities

Support project teams with instrument licensing, translation management, system specification, testing, and deployment activities.
Perform instrument license research and support license acquisition and deployment activities.
Support translation and localization activities, including language gap analysis and coordination with vendors.
Support internal processes related to the implementation and use of COA/eCOA systems across clinical studies.
Collaborate with project teams, clients, and vendors to facilitate the successful setup and delivery of COA/eCOA solutions.
Provide input on training materials for sites and patients in line with study requirements.
Monitor COA/eCOA vendor performance at the study level and escalate issues as appropriate.
Coordinate integration activities between COA/eCOA platforms and other clinical systems (e.g., EDC, IRT/IxRS).
Support oversight of COA/eCOA activities following system go-live.
Assist in identifying and assessing risks associated with the implementation of COA/eCOA systems.
Support training activities for project teams and other stakeholders.
Contribute to vendor management, quality, and continuous improvement activities.
Support business development initiatives, including proposals, client presentations, and vendor-related activities.