Sr. Clinical Research Associate

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

Resumo da oferta

ICON is seeking a Clinical Research Associate to ensure patient safety and data integrity in clinical trials. You will perform monitoring activities, manage site staff, and ensure compliance with regulations. The role involves significant travel and offers a competitive salary with various benefits.

Serviços

Competitive salary

Benefits focused on well-being and work-life balance

Qualificações

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

Responsabilidades

• Complete onsite and remote monitoring activities in accordance with ICH-GCP guidelines.
• Verify the protection of study participants and ensure integrity of clinical data.
• 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 field

Descrição da oferta de emprego

Job Description: Clinical Research Associate

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, enabling a supportive and collaborative work environment. Frequent, consistent communication, both internally and with our client, helps our program stay closely aligned on 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 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 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 and update tracking systems. 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 assessments and management throughout the project, including site health analysis 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, and escalate as appropriate with limited guidance.
12. Assist with non-complex, short-term assignments supporting additional studies or departmental initiatives.
13. Potentially serve as a preceptor, providing training to less experienced team members.

Who you are:

• Undergraduate degree or 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%.
• 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 our people. We prioritize building a diverse culture that rewards high performance and nurtures talent.

Along with a competitive salary, ICON offers various benefits focused on well-being and work-life balance for you and your family.

Learn more about working at ICON: https://careers.iconplc.com/benefits

At ICON, inclusion and belonging are core to our culture. 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. For accommodations during the application process, please visit https://careers.iconplc.com/reasonable-accommodations.

If you're interested but unsure if you meet all requirements, we encourage you to apply—there's a good chance you're the right fit for this or other roles at ICON.