Clinical Research Associate II

ICON; Brasil; Teletrabalho; BRL 80.000 - 100.000; Tempo integral

Resumo da oferta

ICON is seeking a Clinical Research Associate to ensure patient safety and data integrity through independent monitoring of clinical studies. The role involves onsite and remote monitoring, managing site staff, and ensuring compliance with regulations. A supportive work environment promotes collaboration, and the position requires travel. ICON values diversity and offers competitive benefits focused on well-being and work-life balance.

Serviços

Competitive salary

Benefits focused on well-being and work-life balance

Qualificações

• Holder of an undergraduate degree or equivalent in clinical, science, or health-related fields.
• Experienced in supporting clinical trials with solid on-site monitoring background.

Responsabilidades

• Complete onsite and remote monitoring activities in accordance with ICH-GCP guidelines.
• Verify the protection of study participants by confirming informed consent procedures.
• Manage investigative site staff to facilitate trial deliverables.

Conhecimentos

Clinical Trials

Monitoring

Risk Assessment

Communication

Formação académica

Undergraduate degree in clinical, science, or health-related fields

Descrição da oferta de emprego

A Clinical Research Associate is a professional who contributes to accelerated drug, device, or 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, ensures our program aligns closely with shared goals.

We are a comprehensive clinical research organization, powered by healthcare intelligence.

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 close-out.
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 submission.
5. Verify proper management and accountability of Investigational Product (IP).
6. Write and submit reports of investigative site findings, update tracking systems, and escalate deficiencies, issues, and corrective actions as needed.
7. Manage essential documents as required by local regulations and ICH-GCP guidelines before, during, and after a clinical study; assist with resolving investigational site/data queries.
8. Perform key risk assessment and management responsibilities throughout the project, including risk indicator and site health analysis, process evaluation, and project 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 risk with limited guidance, and escalate as appropriate.
12. Assist with non-complex adhoc, short-term assignments supporting additional studies or initiatives.
13. May serve as a preceptor, providing training to less experienced team members.

You are:

1. Holder of an undergraduate degree or equivalent in clinical, science, or health-related fields from an accredited institution; health care professional licensure (e.g., registered nurse) is preferred.
2. Experienced in supporting clinical trials with solid on-site monitoring background.
3. Willing to travel 50-80%.
4. Equivalent education, training, and relevant experience may be considered; fluency in English and 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. Learn more at our benefits page.

At ICON, inclusion and belonging are fundamental. We are committed to providing an accessible, discrimination-free environment. All qualified applicants will receive equal consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. More info at our accommodations page.

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