CTA - Medical Affairs

Overview

The Global Clinical Trial Assistant (Global CTA) performs investigative site recruitment/feasibility, essential document collection and review, clinical status tracking, and in-house site management activities in accordance with the Sponsor and/or ICON's protocol, standard operating procedures (SOPs), ICH/GCP guidelines and all applicable regulatory requirements.

Responsibilities

What you will be doing:

• Performs a variety of routine essential document collection, review, negotiation, to ensure successful site activation and maintenance and close out tasks under general supervision.
• Performs recruitment of study sites, ensuring activities, documents and all other clinical data are accurately tracked and documented for the project lifecycle. Escalates issues as needed.
• Completes submissions and notifications to regulatory authorities, ethics committee and other bodies.
• May serve as a patient management associate (conduct patient interviews, answer questions, follow up on issues).
• Performs and documents clinical data review and query creation, query resolution, offsite central monitoring contacts/visits and site management communications as outlined in the study plans (and/or other processes).
• Sets up and maintains study documentation in applicable systems, e.g., clinical trial management system (CTMS), TMF system, applicable site/sponsor systems according to project protocol, applicable SOPs and project plans.

Qualifications

You are:

• Bachelor's degree or its international equivalent in clinical, science, or health related field.
• Previous experience in clinical research with ethics submissions.
• Clinical trials support or pharmaceutical industry experience preferred.
• Read, write, and speak advanced English; fluent in host country language required.
• 100% remote.

What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include:

• Various annual leave entitlements.
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
• Life assurance.
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.