Sr. Clinical Research Associate

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

Resumo da oferta

A leading clinical research organization is seeking a Clinical Research Associate to ensure patient safety and data integrity through monitoring studies. You will manage site staff, verify compliance with protocols, and perform risk assessments while contributing to a collaborative environment. This role requires a strong background in clinical trials and the ability to travel frequently.

Serviços

Competitive salary

Benefits focused on well-being and work-life balance

Qualificações

• Previous experience supporting clinical trials with solid on-site monitoring expertise.
• Willing to travel 50-80%.

Responsabilidades

• Complete onsite and remote monitoring activities per ICH-GCP guidelines.
• Manage investigative site staff to facilitate trial deliverables.
• Write and submit reports of investigational site findings.

Conhecimentos

Fluent English

Clinical Monitoring

Risk Assessment

Formação académica

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

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 with 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 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 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 resolution of investigational site/data queries.
8. Perform key risk assessments and management responsibilities throughout the project, including site health analysis and process evaluation.
9. Participate in audit preparation and follow-up activities as needed.

Additional duties include:

1. Independently perform various onsite and offsite monitoring visits.
2. Gather and review information for assigned sites, identify inconsistencies, and assess risks with limited guidance.
3. Assist with non-complex ad hoc, short-term assignments supporting additional studies or initiatives.
4. Potentially serve as a preceptor, providing training to less experienced team members.

Qualifications

You are:

• Holding an undergraduate degree or international equivalent in a clinical, science, or health-related field from an accredited institution; health care professional licensure (e.g., registered nurse) is preferred.
• Having previous experience supporting clinical trials with solid on-site monitoring expertise.
• Willing to travel 50-80%.
• Possessing the ability to read, write, and speak fluent 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.

Visit our careers website to learn more about the benefits of working at ICON: 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 need a reasonable accommodation during the application process or to perform essential job functions, 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.