Study Start up Associate Intern

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.That’s our vision. We’re driven by it. And we need talented people who share it.If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

As a Study Start-Up Associate Intern, you will play a vital role in the efficient initiation of clinical trials by ensuring the collection, preparation, review, approval, processing, and tracking of regulatory and site-level critical documents necessary for study site activation. In strict adherence to ICON's standard operating procedures (SOPs) and work practices, as well as Sponsor SOPs, country-specific regulations, and guidelines.  You will contribute to the seamless commencement of clinical trials.

What will you be doing?

• Collect, prepare, and review all regulatory and site-level critical documents required for the initiation of clinical trials. Ensure these documents comply with ICON SOPs, Sponsor SOPs, ICH/GCP principles, and relevant country regulations/guidelines.
• Collaborate with cross-functional teams to facilitate the approval process for study site activation documents. Ensure proper documentation is in place and seek necessary approvals from regulatory authorities and relevant stakeholders.
• Stay updated with applicable country regulations, guidelines, and industry best practices related to clinical trial initiation. Ensure that all documents and processes are in compliance with these requirements.
• Manage the end-to-end process of document preparation, submission, and approval for study site activation. Monitor progress and address any bottlenecks or issues to maintain a streamlined workflow.
• Maintain accurate and up-to-date records of all study start-up activities. Generate regular reports to track the progress of document preparation, submission, and approval.
• Collaborate with internal teams, regulatory authorities, and study sites to facilitate effective communication and timely exchange of required documents. Address any queries or concerns related to study start-up documents.
• Ensure the quality and accuracy of all study start-up documents and processes. Conduct thorough reviews to identify and rectify any errors or discrepancies.
• Identify opportunities for process optimization and efficiency enhancements within the study start-up phase. Propose and implement improvements to streamline workflows and reduce potential delays.

Your Profile

• Must be currently enrolled as a rising senior in a Bachelor’s program or as a Masters level students in a Clinical Research Degree program targeting a Spring 2025 graduation
• Experience with Microsoft Office suite of applications (Word, Excel, PowerPoint, Outlook)
• Confidence in technology use
• Strong organizational and time management skills, with excellent attention to detail
• Superb resourcefulness, critical thinking, and problem-solving skills with solutions focus
• Exemplary communication, teamwork, and interpersonal skills
• Adaptability and ability to shift priorities as business needs change.
• Ability to learn systems, software, and processes quickly.
• Ability to read, write and speak English fluently.
• Availability to work a minimum of 3 days/week(20-40 hours/week)
• Must be 18 years or older
• Program runs September 9, 2024, through May 2nd 2025

To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.

This internship opportunity provides valuable hands-on experience in the crucial study start-up phase of clinical trials. You will have the chance to work closely with experienced professionals, learn about regulatory requirements, and play an integral role in the successful initiation of clinical studies. Your contributions will directly impact the advancement of medical research and the development of innovative treatments for patients worldwide.

*This is an Inten position is onsite at our Wilmington, NC office*Benefits of Working in ICON:Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.ICON 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, 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 through the form below.

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