Study Start Up Associate I

Overview

As a Study Start Up Associate you will play a key player in differentiating ICON by accelerating site start-up through effective execution of regulatory approvals and of site contracts ensuring sites are ready to enrol patients as quickly as possible. This role may serve as Site Activation Lead when appropriate. Ensuring timely collection of critical documents in order to begin patient enrolment. Critical path to study initiation.

Responsibilities

You will be partnering with one of the worlds premier Biopharmaceutical companies. Working across a vast portfolio of medicines and vaccines this company has, over centuries created a strong heritage of delivering innovative treatments and preventive medicines globally

What you will be doing:

• Initiate and coordinate activities and essential documents management towards the compilation of a high-quality site level documents leading to sites initiation approval
• Register investigator sites and systems as required. Update and regularly maintain the registry with accuracy and have it inspection ready
• Work directly and interact with investigator sites to complete critical information and readiness for site activation; inclusive of but not limited to site essential documents components, study contracts contacts, payment information, ethics/IRB submission and status
• Take the lead to resolve issues or concerns and timely escalation of issues where applicable
• Prepare, validate and submit applicable study documents such as ICDs, for internal regulatory/Legal approval within required timelines
• Lead a subset and assist with the overall site activation process and coordinate operational activities to ensure timely site activation
• Take the Lead and Coordinates the compilation of the local or Central Investigator Review Board (IRB) package and submissions to approval of the study
• Coordinate the timely communication, documentation and responses between the sponsor and Central Ethics committee to bring study to approval (country dependent)
• Support investigators sites with local IRB workflow from preparation, submission through approval
• Supports investigator sites, and study teams in preparation for and providing responses to site audits / inspections

Qualifications

Qualifications:

• At least 1-2 years of experience supporting startup and regulatory submissions in Argentina.
• Knowledge of local regulatory authority drug research and development regulations required.
• Clinical trials support or pharmaceutical industry experience required.
• Bachelor in helth degree is a plus.
• Advanced level of English.
• Open to go to the office at least 2 times per week. 

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/benefitsAt 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-accommodationsInterested 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.