Study Start Up Associate II

Study Start Up Associate II (Supporting North America region - US/CAN)

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.

We are currently seeking a Study Start Up Associate II (Site Activation Partner) to join our diverse and dynamic team. As a Study Start Up Associate II at ICON, you will play a pivotal role in leading the initiation of clinical trials, ensuring compliance with regulatory requirements, and contributing to the advancement of innovative treatments and therapies.

In this role you will be responsible for leading or supporting operational activities from start-up to close-out, for assigned studies and investigator sites to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and Sponsor standards.  Responsibility within a country and may span over more than one country depending on the geographical region and business needs.

What you will be doing

• Initiate and coordinate activities and essential documents management during start-up towards the compilation of a high-quality Investigator Initiation Package (IIP) leading to approval for site initiation 

• Support the compilation of the Central Investigator Review Board (IRB) package and submissions to approval of the study (where applicable) and other committees as per country requirements

• Prepare, validate, and submit regulatory documents such as completed IIP, IRB approval forms, FDA 1572/Attestation Form, for internal regulatory approval within required timelines

• Support investigators sites with local IRB workflow from preparation, submission through approval

• Accurately update and maintain clinical trial systems that track site compliance and performance within project timelines

• Maintain ongoing contact and communication with the study team and respond promptly to study team and investigator site requests

• Coordinating and liaising with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation.

• Managing and maintaining comprehensive and accurate records of regulatory submissions, approvals, and correspondence

• Providing guidance and support to study teams on regulatory requirements and best practices for study start-up activities.

• Participating in process improvement initiatives to streamline study start-up processes and enhance efficiency.

Your profile

• Bachelor's degree in life sciences or a related field.

• Minimum of 2 years of experience in clinical research or regulatory affairs, with specific experience in study start-up activities.

• Candidates must have very good level of English and experience working with US, as will provide support to NAM.

• Strong understanding of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulatory requirements.

• Excellent organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously.

• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams

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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