Overview
As a Site Activation Partner you will play a key role in improving the lives of patients by accelerating the development of our customers drugs and devices through innovative solutions.
You will be dedicated resource to one of our clients, be embedded in their working environment, systems and processes.
Responsibilities
What you will be doing:
- Collect, prepare, review, approve, process and track regulatory and site level critical documents required for study site activation in accordance with ICON SOPs/WPs, Sponsor SOPs, applicable country regulations/guidelines and the principles of ICH/GCP.
Play a pivotal role in facilitating the initiation of clinical trials, ensuring compliance with regulatory requirements, and contributing to the advancement of treatments and therapies.
Assist in the preparation and submission of regulatory documents, such as clinical trial applications and ethics committee submissions.
Coordinatine with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation.
Maintain accurate and up-to-date records of regulatory submissions and approvals.
Support study teams in the development of study documents, including protocols, informed consent forms, and investigator brochures.
Participate in study start-up meetings and providing input on regulatory requirements and timelines.
Qualifications
Requirements:
- Bachelor's degree in life sciences or a related field.
- Experience with local ethics submissions (Argentina) in clinical reasearch.
- Fluent Spanish and Advanced English.
- Strong attention to detail and organizational skills.
- Regulatory experience with a focus on submissions (FEFYM) / Provincial committees.
- 100% remote.
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.
