Clinical Research Associate II (São Paulo)

Pharmaceutical Research Associates, Inc; Brasil; Presencial; BRL 20.000 - 35.000; Tempo integral

Resumo da oferta

A leading company in clinical research seeks a Clinical Research Associate to ensure patient safety and data integrity during studies. The role involves both onsite and remote monitoring tasks, supporting trial deliverables, and ensuring compliance with regulatory standards. This position values diversity and offers a collaborative work environment with ongoing training opportunities.

Serviços

Competitive salary

Work-life balance benefits

Training opportunities

Qualificações

• Holding an undergraduate degree or international equivalent.
• Previous experience supporting clinical trials.
• Willing to travel 50-80%.

Responsabilidades

• Complete onsite and remote monitoring activities per ICH-GCP guidelines.
• Ensure the integrity of clinical data.
• Manage investigative site staff.

Conhecimentos

Monitoring

Risk assessment

Data integrity

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.

Responsibilities

What you will be doing:

• 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.
• Verify the protection of study participants by confirming informed consent procedures and protocol adherence in accordance with applicable regulations.
• Ensure the integrity of clinical data and that the study is conducted in compliance with approved protocols, GCP, applicable regulations, and SOPs.
• Manage investigative site staff to facilitate trial deliverables, e.g., subject enrollment and data submission.
• Verify proper management and accountability of Investigational Product (IP).
• Write and submit reports of investigative site findings and update applicable tracking systems. Escalate observed deficiencies, issues, and corrective and preventative actions as appropriate.
• 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.
• Perform key risk assessments and management responsibilities throughout the project, including risk indicator and site health analysis, site process evaluation, and project escalation.
• Participate in audit preparation and follow-up activities as needed.
• Independently perform a variety of onsite and offsite monitoring visit types.
• Gather and review information for assigned sites and identify inconsistencies. Assess risk and escalate as appropriate with limited guidance.
• Assist with non-complex adhoc, short-term assignments supporting additional studies or departmental initiatives.
• May serve as a preceptor, providing training to less experienced 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).
• Having 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. All employees must be fluent in English and the host country's 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: https://careers.iconplc.com/benefits

ICON values inclusion & belonging, providing an inclusive and accessible environment for all candidates. We are committed to a workplace 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. If you need a reasonable accommodation during the application process or to perform essential job functions, contact us through the provided form: https://careers.iconplc.com/reasonable-accommodations

Interested but unsure if you meet all requirements? We encourage you to apply – you might be exactly who we're looking for at ICON.