Senior CRA

ICON Strategic Solutions; Brasil; Teletrabalho; BRL 75.000 - 100.000; Tempo integral

Resumo da oferta

A clinical services company in Brazil is seeking a Clinical Research Associate to join their team. This role involves designing and analyzing clinical trials, ensuring data integrity, and managing investigative site staff. Candidates must have a relevant degree and on-site monitoring experience, with travel requirements between 50-80%. The position includes a competitive salary and various benefits focused on work-life balance.

Serviços

Various annual leave entitlements

Health insurance offerings

Competitive retirement planning

Global Employee Assistance Programme

Life assurance

Flexible optional benefits

Qualificações

• Undergraduate degree or international equivalent in clinical, science, or health-related field.
• Previous experience supporting clinical trials including solid on-site monitoring experience.
• Travel required 50-80%.

Responsabilidades

• Completes onsite and remote monitoring activities.
• Ensures the integrity of clinical data and compliance with protocols.
• Manages investigative site staff for trial deliverables.

Conhecimentos

On-site monitoring experience

Fluent in English

Risk assessment

Clinical trial support

Formação académica

Undergraduate degree in clinical or health-related field

Descrição da oferta de emprego

We are currently seeking a Clinical Research Associate to join our diverse and dynamic team. As a Clinical Research Associate at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies.

What you will be doing:

• Completes onsite and remote monitoring activities in accordance with all ICH-GCP guidelines, applicable regulations, SOPs and study processes.
• Verifies the protection of study participants by confirming informed consent procedures and protocol have been performed in accordance to 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 such as subject enrollment and data deliverables.
• Verifies proper management and accountability of Investigational Product (IP).
• Writes and submits reports of investigational site findings and updates applicable tracking systems, escalating 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 site and identifies inconsistencies, assessing risk and escalating as appropriate with limited guidance from project and functional management.
• Assists with non-complex adhoc, short-term assignments in support of additional studies or departmental initiatives.
• Mays serve as preceptor, providing training to less experienced clinical team members.

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 in CROs or pharma companies.
• Travel is required 50-80%.
• All employees must read, write and speak fluent English and host country language.

What ICON can offer you:

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.

• Various annual leave entitlements.
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximise 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, subsidised travel passes, health assessments and more.

Visit our careers website to read 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’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, colour, 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 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.