CRA II

Pharmaceutical Research Associates, Inc; Brasil; Presencial; BRL 80.000 - 120.000; Tempo integral

Resumo da oferta

A leading clinical research organization is seeking a Clinical Research Associate to ensure patient safety and data integrity in clinical studies. The role involves monitoring activities, managing site staff, and compliance with protocols. Successful candidates will hold a relevant degree and have experience in clinical trials.

Serviços

Competitive salary

Work-life balance benefits

Qualificações

• Holding an undergraduate degree or international equivalent.
• Previous experience supporting clinical trials.
• Fluency in English and local language required.

Responsabilidades

• Complete onsite and remote monitoring activities.
• Ensure integrity of clinical data.
• Manage investigative site staff for trial deliverables.

Conhecimentos

On-site monitoring experience

Clinical trials support

Risk assessment

Formação académica

Undergraduate degree in clinical or health-related fields

Health care professional licensure (e.g., registered nurse)

Descrição da oferta de emprego

Overview

A Clinical Research Associate is a professional who contributes to accelerated drug/device/outcomes research through independent monitoring of studies to ensure patient safety and data integrity.

You will be joining a program that takes an extensive co-monitoring approach, enabling a supportive and collaborative work environment. Frequent, consistent communication, both internally and with our client, positions our program to be closely aligned on our shared goals.

Responsibilities

What you will be doing:

1. Complete onsite and remote monitoring activities in accordance with all ICH-GCP guidelines, applicable regulations, SOPs, and study processes. Activities include qualifying potential investigative sites, initiating clinical trials, maintaining study files, providing instructions to site personnel, and study closeout.
2. Verify the protection of study participants by confirming informed consent procedures and protocol adherence in accordance with applicable regulations.
3. Ensure the integrity of clinical data and that the study is conducted in compliance with the approved protocol, GCP, applicable regulations, and SOPs.
4. Manage investigative site staff to facilitate trial deliverables, e.g., subject enrollment and data delivery.
5. Verify proper management and accountability of Investigational Product (IP).
6. Write and submit reports of investigational site findings and update applicable tracking systems. Escalate observed deficiencies, issues, and corrective/preventive actions as appropriate.
7. Manage essential documents as required by local regulations and ICH-GCP guidelines before, during, and after a clinical study; assist with resolution of investigational site/data queries.
8. Perform key risk assessments and management responsibilities throughout the project, including risk indicator and site health analysis, process evaluation, and escalation.
9. Participate in audit preparation and follow-up activities as needed.
10. Perform a variety of onsite and offsite monitoring visits independently.
11. Gather and review information for assigned sites, identify inconsistencies, assess risks, and escalate as appropriate with limited guidance.
12. Assist with non-complex adhoc, short-term assignments supporting additional studies or departmental initiatives.
13. May serve as preceptor, providing training to less experienced team members.

Qualifications

You are:

• Holding an undergraduate degree or international equivalent in clinical, science, or health-related fields from an accredited institution; health care professional licensure (e.g., registered nurse).
• Having previous experience supporting clinical trials, including solid on-site monitoring experience.
• Willing to travel 50-80%.
• Equivalent education, training, and relevant experience may be considered in place of formal education and experience. Fluency in English and the host country language is required.

What ICON can offer you:

Our success depends on the quality of our people. We prioritize building a diverse culture that rewards high performance and nurtures talent. In addition to a competitive salary, ICON offers various benefits focused on well-being and work-life balance for you and your family.

Visit our careers website to learn more: https://careers.iconplc.com/benefits

At ICON, inclusion and belonging are fundamental to our culture. We are committed to providing an inclusive, accessible environment and a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration. If you require reasonable accommodation during the application process or to perform essential job functions, please let us know through the provided form: https://careers.iconplc.com/reasonable-accommodations

Interested but unsure if you meet all requirements? We encourage you to apply—perhaps you are exactly what we're looking for, whether for this or other roles at ICON.