Clinical Research Associate II (São Paulo)

ICON; São Paulo; Híbrido; USD 40.000 - 60.000; Tempo integral

Resumo da oferta

ICON, a leading clinical research organization, seeks a Clinical Research Associate to enhance drug/device research. This role involves independent study monitoring, ensuring compliance with regulations, and facilitating effective trial management. The ideal candidate holds a relevant degree and has experience in clinical trials, with strong on-site monitoring skills.

Serviços

Competitive salary

Benefits focused on well-being and work-life balance

Diverse work culture

Qualificações

• Undergraduate degree or equivalent in a clinical, science, or health-related field.
• Previous clinical trial support experience with solid on-site monitoring.
• Willingness to travel 50-80%.

Responsabilidades

• Completing onsite and remote monitoring activities in line with ICH-GCP guidelines.
• Ensuring study participant safety and data integrity.
• Managing investigative site staff to facilitate trial deliverables.

Conhecimentos

Clinical trial support

On-site monitoring

Data integrity

Risk assessment

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 join a program that takes an extensive co-monitoring approach, fostering a supportive and collaborative work environment. Frequent, consistent communication, both internally and with our client, aligns our program with shared goals.

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

What you will be doing:

• Completing 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.
• Verifying the protection of study participants by confirming informed consent procedures and protocol adherence in accordance with applicable regulations.
• Ensuring the integrity of clinical data and that the study is conducted in compliance with the approved protocol, GCP, applicable regulations, and SOPs.
• Managing investigative site staff to facilitate trial deliverables, such as subject enrollment and data collection.
• Verifying proper management and accountability of Investigational Product (IP).
• Writing and submitting reports of investigational site findings, updating tracking systems, and escalating deficiencies, issues, and corrective actions as appropriate.
• Managing essential documents as required by local regulations and ICH-GCP guidelines before, during, and after a clinical study; assisting with resolution of site/data queries.
• Performing key risk assessments and management responsibilities throughout the project, including site health analysis and project escalation.
• Participating in audit preparation and follow-up activities as needed.
• Performing a variety of onsite and offsite monitoring visits independently.
• Gathering and reviewing information for assigned sites, identifying inconsistencies, assessing risk, and escalating as needed.
• Assisting with non-complex ad hoc, short-term assignments supporting additional studies or initiatives.
• Potentially serving as a preceptor, providing training to less experienced team members.

You are:

• Holding an undergraduate degree or equivalent in a clinical, science, or health-related field from an accredited institution; health care professional licensure (e.g., registered nurse).
• Having previous clinical trial support experience, including solid on-site monitoring.
• Willing to travel 50-80%.
• Possessing an equivalent combination of education, training, and experience; fluent in English and the host country language.

What ICON can offer you:

Our success depends on 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.

ICON values inclusion and belonging, providing an accessible environment for all candidates. We are committed to equal opportunity employment and reasonable accommodations. For assistance, visit this link.

If you're 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.