Clinical Research Associate I

Pharmaceutical Research Associates, Inc; Brasil; Presencial; BRL 50.000 - 70.000; Tempo integral

Resumo da oferta

A leading clinical research organization is seeking a Clinical Research Associate to ensure patient safety and data integrity through independent monitoring of studies. The role involves managing site staff, conducting risk assessments, and ensuring compliance with protocols. The ideal candidate will have a degree in a relevant field and experience in clinical trials. Join a collaborative team focused on advancing healthcare outcomes.

Serviços

Competitive Salary

Work-Life Balance Benefits

Qualificações

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

Responsabilidades

• Complete onsite and remote monitoring activities according to ICH-GCP guidelines.
• Verify the protection of study participants and ensure data integrity.
• Manage investigative site staff to facilitate trial deliverables.

Conhecimentos

Clinical Trials

Monitoring

Risk Assessment

Communication

Team Collaboration

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 close-out.
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 investigative site findings and update applicable tracking systems. Escalate observed deficiencies, issues, and corrective and 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 resolution of investigational site/data queries.
8. Perform key risk assessment 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. Independently perform a variety of onsite and offsite monitoring visit types.
11. Gather and review information for assigned sites, identify inconsistencies, assess risk, 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 preceptor, providing training to less experienced clinical team members.

Qualifications

You are:

• Holding 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) is also acceptable.
• Having 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 in lieu of formal education and experience. 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. Alongside 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 and belonging are fundamental to our culture and values. We are committed to providing an inclusive, accessible environment for all candidates and a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration 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 essential job functions, please inform us through the provided form: https://careers.iconplc.com/reasonable-accommodations

If you are interested in the role but unsure if you meet all requirements, we encourage you to apply. You may be exactly what we are looking for at ICON, whether for this or other roles.