As a Study Start-Up CRA (SSU CRA) will be responsible of creating and endorsing submission packages related to the country or site, following ICH, GCP, and all relevant regulations, laws, guidelines, and ethical standards, within specific deadlines and quality standards, if applicable (depending on the country). Responsible for examining and endorsing critical documents at the site level for site activation, in accordance with regulatory/sponsor requirements, within specific deadlines and quality standards.

Main activities

• Perform feasibility, site identification, and other study start up activities, as assigned.

• Prepare, review and submit submissions to ethics and regulatory and other relevant authorities or agencies (if required) in order to obtain all necessary authorizations/approvals pertaining to the clinical trial conduct.

• Develop and finalize Country Specific ICFs (if applicable for country).

• Prepare and finalize Country Specific xml files (if applicable for region).

• Perform independent quality review of submission packages. 

• Collect and maintain (or have oversight if applicable) current Regulatory/Competent Authority (CA) and Ethics Committee (EC) submission information, and similar information for other related organizations, for the assigned countries and update relevant ICON or client information system.

• Responsible for the coordination of translations for documents required for submission (if applicable for country).

• Perform timely and accurate data entry of regulatory documents, submission status and maintenance of Country/Investigator information in the appropriate clinical trial management system in collaboration with the CTAs (if applicable for country).

• Route incoming correspondence, internal documentation, etc., as appropriate.

• Responsible for the timely follow-up for queries made by EC and CA (if applicable for country).

• Responsible for the review and approval of critical documents required for site activation and IP Release, as appropriate.

• Attend study team meetings as required.

• Be familiar with ICH GCP, relevant country regulations/guidelines and ICON/client SOPs.

• Assist and provide support to the RCTM to maximize submission effectiveness, minimize timelines and ensure sponsor satisfaction.

• Undertake other reasonably related duties as may be assigned from time to time

Requisitions

• Bachelor’s degree in a health, life sciences or medical fields.
• Experience with study start-up activities and on-site monitoring experience. 
• Availability to travel when required.
• Fluent English and Spanish (read, write and speak)

• Based in Ciudad de Buenos Aires / Buenos Aires. 

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 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 specialised 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, among others

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 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.