Study Start Up Associate II (EC submissions)

Site Specialist II

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

Responsibilities:

• Proficient knowledge of ICON SOPs/WPs, ICH/GCP and applicable country regulations/guidelines and ICON systems.

• Support Site Partners to collect, review, organize and assemble initial start-up and maintenance submission packages to Central EC/IRB, Local EC/IRB, Competent Authorities, any other local regulatory authorities as required by countries and in accordance with ICH/GCP and applicable country regulations/guidelines.

• Support collection and assembling of all documents needed in the Critical Document Package (CDP) and/or those required for site activation, ensuring that Sponsor and Investigator obligations are being met and are in compliance with applicable requirements and ICH/GCP guidelines.

• Support coordination of all necessary translations required for any start-up documentation.

• Perform timely and accurate progress data entry of all documents collected from sites and of the relevant study site activation activities into the appropriate tracking systems and tools.

• Participate to internal study review meetings with study teams to provide updates on site progress in document collection and on the executed site activation tasks.

• Accurately forecast Site Activation plans and ensure that they are reflected accurately in ICON’s systems and proactively follow through for achievement to plan.

• Ensure accuracy and timely completeness of Trial Master File (TMF) documents submitted during start-up and perform a Quality Control (QC) review of files before transfer to maintenance for filing in TMF.

• Attend study team meetings as required

What you need to succeed in the role:

• Bachelor’s Degree preferably in Life Sciences

• Minimum of 1 years’ experience or understanding of clinical study start up requirements and activities.

• Knowledge of local and/or international regulatory processes, including submissions to regulatory authorities and ethics committees.

• Ability to read and understand clinical protocols, regulatory documents, and study-specific processes.

• Strong attention to detail and organizational skills.

• Ability to work independently and manage multiple tasks simultaneously in a fast-paced environment.

• Excellent communication skills both in English and Spanish

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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, LifeWorks, 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 site to read more about the benefits ICON offers.

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, 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 or submit a request here

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.

Are you a current ICON Employee? Please click here to apply