Study Start Up Associate I

Há 3 dias

Brasil ICON Tempo inteiro

Job Summary: We are seeking a highly skilled Study Start Up Associate I to join our team at ICON. As a key member of our team, you will play a vital role in accelerating the development of our customers' drugs and devices through innovative solutions.

Key Responsibilities:

  1. Perform investigator recruitment activities, utilizing phone scripts, questionnaires, study site materials, and other tools for evaluating investigative sites.
  2. Utilize the Clinical Trial Management System (CTMS) to ensure investigator recruitment activities are accurately tracked.
  3. Perform essential document collection, review, maintenance, and close-out activities, ensuring compliance with applicable local regulatory requirements and ICH/GCP guidelines.
  4. Support investigators and investigative staff in fulfilling obligations regarding local submissions according to local regulatory and Institution Review Board (IRB)/Independent Ethics Committee (IEC) requirements.
  5. Perform study tracking via the CTMS or Sponsor designated system to ensure that study files are current, accurate, and complete.
  6. Document site and Sponsor contact and study interactions in a timely and professional manner.
  7. Assist with the resolution of investigational site/data queries.
  8. Provide quality review of the informed consent template.
  9. Follow up with sites for trial invoices and ensure the CTMS is accurately updated to allow timely processing of Investigator Payments.

Requirements:

  • Knowledgeable of local regulatory authority drug research and development regulations.
  • Experienced with ethical submission (CEP and CONEP).
  • Possess clinical trials support or pharmaceutical industry experience.
  • Fluent in advanced English.

About ICON: 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 designed to be competitive within each country and focused on well-being and work-life balance opportunities for you and your family.

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