Clinical Research Associate I

ICON; Brasil; Teletrabalho; BRL 60.000 - 80.000; Tempo integral

Resumo da oferta

Join a leading clinical research organization as a Clinical Research Associate, where you will oversee clinical trials, ensuring compliance with regulations and participant safety. This role emphasizes collaboration and communication within a diverse and inclusive environment, offering competitive salary and benefits focused on well-being.

Serviços

Competitive salary

Benefits focused on well-being and work-life balance

Qualificações

• Experience supporting clinical trials with solid on-site monitoring.
• Fluency in English and host country language required.

Responsabilidades

• Completes onsite and remote monitoring activities per ICH-GCP guidelines.
• Verifies protection of study participants and data integrity.
• Manages investigative site staff and facilitates 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/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.

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

What you will be doing:

1. Completes onsite and remote monitoring activities in accordance with all ICH-GCP guidelines, applicable regulations, SOPs, and study processes, including qualifying potential investigative sites, initiating clinical trials, maintaining study files, providing instructions to site personnel, and study close-out.
2. Verifies the protection of study participants by confirming informed consent procedures and protocol adherence according to applicable regulations.
3. Ensures the integrity of clinical data and that the study is conducted in compliance with approved protocol, GCP, applicable regulations, and SOPs.
4. Manages investigative site staff to facilitate trial deliverables such as subject enrollment and data submission.
5. Verifies proper management and accountability of Investigational Product (IP).
6. Writes and submits reports of investigative site findings, updates tracking systems, and escalates deficiencies, issues, and corrective actions as appropriate.
7. Manages essential documents as required by local regulations and ICH-GCP guidelines before, during, and after a clinical study; assists with resolving investigational site/data queries.
8. Performs key risk assessments and management responsibilities, including site health analysis, process evaluation, and project escalation.
9. Participates in audit preparation and follow-up activities as needed.
10. Independently performs various onsite and offsite monitoring visits.
11. Gathers and reviews information for assigned sites, identifies inconsistencies, assesses risk, and escalates as needed with limited guidance.
12. Assists with non-complex ad hoc, short-term assignments supporting additional studies or initiatives.
13. May serve as a preceptor, providing training to less experienced team members.

You are:

1. 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).
2. Having previous experience supporting clinical trials, including solid on-site monitoring experience.
3. Willing to travel 50-80%.
4. Note: Equivalent combinations of education, training, and relevant experience may be considered. All employees must be fluent in English and the host country language.

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 careers website.

At ICON, inclusion and belonging are fundamental. We are committed to providing an inclusive, accessible environment free of discrimination and harassment. Qualified applicants will receive equal consideration regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. If you need a reasonable accommodation in the application process or to perform job functions, please inform us through this form.

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