CTA

Pharmaceutical Research Associates, Inc; Brasil; Presencial; BRL 30.000 - 70.000; Tempo integral

Resumo da oferta

Join a leading clinical research organization as a Clinical Trial Assistant (CTA) where you will play a vital role in coordinating and administering study activities. This position involves working closely with local study teams to ensure the quality and consistency of deliverables throughout the study lifecycle. You will be responsible for document management, compliance with regulations, and facilitating communication between various stakeholders. This forward-thinking company values diversity and offers a supportive environment focused on well-being and work-life balance. If you are passionate about making a difference in clinical research, this opportunity is for you.

Serviços

Various annual leave entitlements

Health insurance offerings

Competitive retirement planning

Global Employee Assistance Programme

Life assurance

Flexible optional benefits

Qualificações

• Bachelor/Master degree required in a relevant field.
• Experience in clinical research or administrative roles within the pharmaceutical industry.

Responsabilidades

• Assist in coordination and administration of study activities.
• Ensure compliance with local and regional legislation.

Conhecimentos

Planning/Organizational Skills

Problem Solving

Team Player

Advanced English

French

Formação académica

Bachelor's Degree

Master's Degree

Ferramentas

eTMF

ISF

Descrição da oferta de emprego

Overview

As a CTA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Responsibilities

What you will be doing:

CTA assists in the coordination and administration of the study activities from the start up to execution and close out, and within the Local Study Team to ensure quality and consistency of interventional study deliverables to time, cost and quality objectives.

• Collects, assists in preparation, reviews and tracks documents for the application process as well as coordination and tracking of study materials and equipment.
• Assists in submission of proper application/documents to EC/IRB and, where appropriate to Regulatory Authorities.
• Interfaces with Investigators, external service providers and CRAs during the document collection process.
• Local administrative main contact and works closely with the CRAs and/or the LSAD for the duration of the study.
• Set-up and maintenance of the local eTMF and ISF including document tracking in accordance with ICH-GCP and local requirements.
• Ensures essential documents are uploaded in a timely manner to maintain the eTMF “Inspection Readiness” and study documents are ready for final archiving and completion of local part of the eTMF and supports the CRA in the close out activities for the ISF.
• Prepares and/or supports contract preparation at a site level (with the exception of countries where there is a specific role dedicated to preparing site contracts).
• Leads the practical arrangements and contributes to the preparation of internal and external meetings. Responsible for printing and distribution of documents such as letters and meeting minutes, and for handling and archiving of study/country related e-mails.
• Interfaces with Data Management Centre and/or Data Management, Global Clinical Solutions representatives to facilitate the delivery of study related documents/material.
• Ensures compliance with local, national and regional legislation, as applicable.

Qualifications

You are:

• Bachelor/Master degree.
• Experience as Study Coordinator or any other administrative position within Pharmaceutical Industry.
• Excellent planning/organizational skills.
• Problem solving attitude.
• Strong team player.
• Advanced English is required / French is a plus.

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 designed to be competitive within each country and 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.

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits.

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below: https://careers.iconplc.com/reasonable-accommodations.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.