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Study Start Up Associate I

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ICON plc

Sep 24, 2024

  • Job
    Full-time
    Mid Level
  • Research & Development
    Healthcare
  • Quick Apply

AI generated summary

  • You must have at least 3 years of experience in clinical study start-up and be familiar with Essential Document review and the Greenlight Package.
  • You will review essential documents, update clinical systems, ensure TMF accuracy, communicate progress, and support various tasks while adhering to guidelines and maintaining organization.

Requirements

  • Minimum of 3 years’ experience or understanding of clinical study start up requirements and activities.
  • Need experience with Essential Document review /Greenlight Package

Responsibilities

  • Review of site level essential documents ensuring that Sponsor and Investigator obligations are being met and are in compliance with ICON SOPs/WIs, Sponsor SOPs, applicable country requirements and ICH/GCP guidelines.
  • Update systems in a timely and accurate way, maintaining site-related data in applicable clinical systems according to procedures and guidelines.
  • Preparation and Submission of Investigational Product Release Pack.
  • Ensure accuracy and timely completeness of Trial Master File (TMF) documents by submitting the documents for filing to TMF during start-up.
  • Perform timely and accurate task progress communication.
  • Be highly organized in an environment with shifting priorities.
  • Interact successfully with internal stakeholders.
  • Performs all tasks in accordance with applicable guidelines, (e.g., ICH-GCP), company and sponsor SOPs, project plan, study-specific processes, local regulatory requirements.
  • Flexible to support on various other tasks apart from document management process.

FAQs

What is the job title for this position?

The job title is Study Start Up Associate I.

What type of organization is ICON plc?

ICON plc is a world-leading healthcare intelligence and clinical research organization.

How many years of experience are required for this position?

A minimum of 3 years’ experience or understanding of clinical study start-up requirements and activities is required.

What are some key responsibilities of the Study Start Up Associate I?

Key responsibilities include reviewing site-level essential documents, updating systems with site-related data, preparing and submitting Investigational Product Release Pack, ensuring accuracy of Trial Master File (TMF) documents, and performing task progress communication.

Is experience with Essential Document review necessary for this role?

Yes, experience with Essential Document review/Greenlight Package is required.

What values drive the culture at ICON?

ICON's culture is driven by four key values: Accountability & Delivery, Collaboration, Partnership, and Integrity.

What type of environment can employees expect to work in at ICON?

Employees can expect to work in a dynamic and supportive environment with some of the brightest and friendliest people in the sector.

What benefits does ICON offer its employees?

ICON offers competitive salary packages, various health-related benefits, retirement plans, annual bonuses, and a range of additional benefits designed for well-being and work-life balance.

Are there opportunities for professional growth at ICON?

Yes, ICON encourages a culture that rewards high performance and nurtures talent, providing opportunities for professional growth.

Is ICON an equal opportunity employer?

Yes, ICON is committed to providing a workplace free of discrimination and harassment and considers all qualified applicants equally, regardless of various factors such as race, gender, or disability.

What should I do if I need a reasonable accommodation during the application process?

If you need a reasonable accommodation for any part of the application process, please let ICON know through the provided form.

Can I apply for this position even if I don't meet all the requirements?

Yes, you are encouraged to apply regardless of whether you meet all the requirements, as you may still be the right fit for the role.

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ICON plc

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times. We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.