Study Start-Up CRA

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)

Why ICON?

At ICON, we embrace new perspectives and empower our people to write their own paths forward. We are a culturally diverse company with over 40,000 talented and ambitious people with varied skills, perspectives & backgrounds working together across 40 countries.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and 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.

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.