In-House CRA

Pharmaceutical Research Associates, Inc; Brasil; Presencial; BRL 40.000 - 80.000; Tempo integral

Resumo da oferta

Join a leading clinical research organization as an In-House CRA, where you will play a vital role in managing clinical trials. This position offers the chance to work closely with sites and investigators, ensuring compliance with regulations and maintaining high standards of data integrity. You'll be part of a diverse and inclusive culture that values your contributions and supports your professional growth. With competitive salaries and a range of benefits focused on well-being and work-life balance, this role is perfect for those passionate about making a difference in healthcare. Don't miss the opportunity to be part of an innovative team!

Serviços

Various annual leave entitlements

Health insurance offerings

Competitive retirement planning

Global Employee Assistance Programme

Life assurance

Flexible optional benefits

Qualificações

• Bachelor's degree in health, life sciences, or related fields.
• Experience in clinical research and ethics submissions.
• Knowledge of ICH-GCP regulations.

Responsabilidades

• Serve as primary contact for sites and investigators.
• Conduct remote site management activities.
• Maintain professional relationships with study teams and sponsors.

Conhecimentos

Clinical Research

Communication Skills

Project Management

Regulatory Knowledge (ICH-GCP)

Data Management

Formação académica

Bachelor's degree in health or life sciences

Descrição da oferta de emprego

Overview

As an In-House CRA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Responsibilities

What you will be doing:

• Serve as the primary in-house contact for sites and investigators participating in studies.
• Conducts and completes remote site management activities, with support as needed, according to applicable SOPS and the Study Monitoring Plan.
• To contact Clinical sites for specific requests (e.g. enrolment updates, missing documentation, data entry timeliness, data query follow-up, CDA finding follow-up, and action Item resolution or other sponsor specific CRA tasks.
• Takes responsibility for project tasks and sees these tasks through to successful completion, with support.
• Maintains a professional interpersonal relationship with study team, sites, and Sponsor.
• Participates in QA Audits as needed.
• Regularly attends and contributes to project specific and departmental meetings.
• Maintains Sponsor and patient confidentiality.

Qualifications

• Bachelor's degree in health, life sciences or related fields.
• Experience in clinical research providing support for the studies and ethics submissions.
• Comprehensive knowledge and understanding of ICH-GCP and other relevant regulations for the conduct of clinical trials related to pharmaceuticals, biologics, medical devices and combination products.
• Good English level (conversation and writting) and Fluent Portuguese.
• Based in São Paul or greater São Paulo region.

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

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefitsAt ICON, inclusion & belonging are fundamental to our culture and values. 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, colour, 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-accommodationsInterested 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.