Clinical Research Associate II or Sr.

Pharmaceutical Research Associates, Inc; Brasil; Presencial; BRL 60.000 - 80.000; Tempo integral

Resumo da oferta

A leading clinical research organization seeks a Clinical Research Associate to ensure patient safety and data integrity. The role involves monitoring clinical trials, managing site staff, and ensuring compliance with regulations. Join a collaborative team focused on high performance and well-being.

Serviços

Competitive salary

Benefits focused on well-being and work-life balance

Qualificações

• Previous experience supporting clinical trials with onsite monitoring.
• Fluency in English and host country language is required.

Responsabilidades

• Complete onsite and remote monitoring activities.
• Verify protection of study participants and ensure data integrity.
• Manage investigative site staff and facilitate trial deliverables.

Conhecimentos

Clinical Research

Monitoring

Communication

Risk Assessment

Formação académica

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

Descrição da oferta de emprego

Overview

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.

Responsibilities

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 closeout.
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 collection.
5. Verify proper management and accountability of Investigational Product (IP).
6. Write and submit reports of investigative site findings and update applicable tracking systems. Escalate observed deficiencies, issues, and corrective and preventative action plans as appropriate.
7. Manage essential documents as required by local regulations and ICH-GCP guidelines before, during, and after a clinical study; assist with resolution of investigational site/data queries.
8. Perform key risk assessment and management responsibilities throughout the project, including site health analysis, process evaluation, and project escalation.
9. Participate in audit preparation and follow-up activities as needed.
10. Independently perform various onsite and offsite monitoring visits.
11. Gather and review information for assigned sites, identify inconsistencies, assess risk, and escalate as appropriate.
12. Assist 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.

Qualifications

You are:

• Hold 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).
• Have previous experience supporting clinical trials, including solid on-site monitoring experience.
• Willing to travel 50-80%.
• Equivalent combinations of 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 a range of benefits focused on well-being and work-life balance for you and your family. Visit our careers website to learn more: https://careers.iconplc.com/benefits

At ICON, inclusion & belonging are fundamental to our culture and values. We are committed to providing an inclusive and accessible environment for all candidates. If you require reasonable accommodations during the application process or to perform your duties, please let us know through the provided form: https://careers.iconplc.com/reasonable-accommodations

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