Sr. Clinical Research Associate

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

Resumo da oferta

Join a leading clinical research organization as a Clinical Research Associate, where you'll ensure patient safety and data integrity through independent monitoring. You'll engage in both onsite and remote activities, working closely with investigative sites to support clinical trials. This role requires strong communication skills and a commitment to compliance with regulatory standards. ICON offers a competitive salary and a range of benefits focused on well-being and work-life balance.

Serviços

Competitive salary

Benefits focused on well-being and work-life balance

Qualificações

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

Responsabilidades

• Complete onsite and remote monitoring activities according to ICH-GCP guidelines.
• Ensure integrity of clinical data and compliance with protocols.
• 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

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.

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 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, data collection.
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 observed deficiencies, issues, and corrective/preventive 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 resolving 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 a preceptor, providing training to less experienced clinical team members.

You are:

• An undergraduate degree or international 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 combination of education, training, and relevant experience may be considered. All employees must be fluent in 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.

Along with 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. We are committed to providing an inclusive, accessible environment and 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 require a reasonable accommodation during the application process or to perform essential job functions, please let us know via https://careers.iconplc.com/reasonable-accommodations.

Interested in the role but unsure if you meet all requirements? We encourage you to apply—your profile might be exactly what we’re looking for.