CRA II

Pharmaceutical Research Associates, Inc; Brasil; Presencial; BRL 60.000 - 100.000; Tempo integral

Resumo da oferta

An established industry player is seeking a Clinical Research Associate to enhance drug/device research through effective monitoring. In this role, you will ensure patient safety and data integrity, working closely with investigative sites to facilitate clinical trials. You will engage in both onsite and remote monitoring, ensuring adherence to ICH-GCP guidelines and regulatory standards. This position offers a collaborative work environment with opportunities for professional growth and development. If you're passionate about clinical research and eager to contribute to impactful studies, this role could be your next great opportunity!

Serviços

Various annual leave entitlements

Health insurance offerings

Competitive retirement planning

Global Employee Assistance Programme

Life assurance

Flexible optional benefits

Qualificações

• Experience in clinical trial monitoring with a focus on data integrity and patient safety.
• Strong understanding of ICH-GCP guidelines and regulatory compliance.

Responsabilidades

• Conduct onsite and remote monitoring activities ensuring compliance with regulations.
• Verify informed consent procedures and manage investigative site staff.

Conhecimentos

Clinical Trial Monitoring

Risk Assessment

Data Integrity

Regulatory Compliance

Communication Skills

Formação académica

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

Health care professional licensure (e.g., registered nurse)

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 that enables 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:

• Completes 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.
• Verifies the protection of study participants by confirming informed consent procedures and protocol have been performed in accordance with applicable regulations.
• Ensures the integrity of clinical data and that the study is conducted in compliance with approved protocol, GCP, applicable regulations and SOPs.
• Manages the investigative site staff to facilitate trial deliverables, e.g., subject enrollment, data deliverables.
• Verifies proper management and accountability of Investigational Product (IP).
• Writes and submits reports of investigational site findings and updates applicable tracking systems. Escalates observed deficiencies, issues, and corrective and preventative action plans as appropriate.
• Manages essential documents as required by local regulations and ICH-GCP guidelines before, during and after a clinical study; assists with resolution of investigational site/data queries.
• Performs key risk assessment and management responsibilities throughout the project, including key risk indicator and site health analysis, site process evaluation, and project escalation.
• Participates in audit preparation and follow-up activities as needed.
• Independently performs a variety of onsite and offsite monitoring visit types.
• Gathers and reviews information for assigned sites and identifies inconsistencies. With limited guidance from project and functional management, assesses risk and escalates as appropriate.
• Assists with non-complex ad hoc, short-term assignments in support of additional studies or departmental initiatives.
• May serve as preceptor, providing training to less experienced clinical team members.

Qualifications

You are:

• Undergraduate degree or international equivalent in clinical, science, or health-related field from an accredited institution; health care professional licensure, i.e., registered nurse.
• Previous experience supporting clinical trials including solid on-site monitoring experience.
• Travel is required 50-80%.
• Equivalent combination of education, training, and relevant experience may be considered in place of the education and experience stated above. All employees must read, write and speak fluent English and host country language.

What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work-life balance opportunities for you and your family. Our benefits examples include:

• Various annual leave entitlements.
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance.
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits. At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organization. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below: https://careers.iconplc.com/reasonable-accommodations. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.