Clinical Research Associate II or Sr. (São Paulo)

ICON; São Paulo; Híbrido; BRL 20.000 - 80.000; Tempo integral

Resumo da oferta

ICON is seeking a Clinical Research Associate to contribute to accelerated drug/device research through independent study monitoring. The role involves ensuring patient safety and data integrity while supporting clinical trials via comprehensive onsite and remote monitoring activities. Ideal candidates will have a relevant undergraduate degree and clinical trial experience, with a strong commitment to compliance with regulatory standards.

Serviços

Competitive salary

Benefits focused on well-being and work-life balance

Diverse and inclusive culture

Qualificações

• Fluency in English and the host country language.
• Previous experience supporting clinical trials with solid on-site monitoring experience.
• Willingness to travel 50-80%.

Responsabilidades

• Complete onsite and remote monitoring activities per ICH-GCP guidelines.
• Manage investigative site staff for trial deliverables.
• Verify informed consent procedures and protocol adherence.

Conhecimentos

Clinical monitoring

Data integrity

Communication

Formação académica

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

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.

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 according to 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, data submission.
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 deficiencies, issues, and corrective/preventative 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 resolving investigational site/data queries.
8. Perform key risk assessments and management responsibilities throughout the project, including risk indicator and site health analysis, site 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 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 a preceptor, providing training to less experienced clinical team members.

You are:

• Holder of an undergraduate degree or international equivalent in clinical, science, or health-related field from an accredited institution; health care professional licensure (e.g., registered nurse).
• Previous experience supporting clinical trials, including solid on-site monitoring experience.
• Willing to travel 50-80%.
• *An equivalent combination 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 a range of benefits focused on well-being and work-life balance for you and your family. More details are available at: https://careers.iconplc.com/benefits

At ICON, inclusion & belonging are fundamental. We are committed to providing an inclusive, accessible environment for all candidates. We do not discriminate and offer equal consideration for employment regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. If you require a reasonable accommodation during the application process or to perform your duties, please inform us through the provided link: https://careers.iconplc.com/reasonable-accommodations

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.