Set Up Specialist

IRE • Raleigh, NY

2d

About The Position

We are currently seeking a Set Up Specialist to join our diverse and dynamic team. As a Set Up Specialist at ICON, you will play a pivotal role in coordinating the initial stages of clinical trials by ensuring that all operational and logistical elements are in place for the successful execution of studies. You will contribute to the advancement of innovative treatments and therapies by facilitating efficient study setup processes and ensuring compliance with regulatory requirements.

Requirements

• Bachelor’s degree in a relevant field such as life sciences, clinical research, or healthcare management.
• Experience in clinical trial setup, regulatory submissions, or site management, preferably within the pharmaceutical or biotechnology industry.
• Strong understanding of clinical trial processes, regulatory requirements, and GCP guidelines.
• Excellent organizational skills and attention to detail, with the ability to manage multiple setup tasks simultaneously.
• Strong communication and interpersonal skills, with the ability to collaborate effectively with diverse teams and stakeholders.

Responsibilities

• Coordinating the setup of clinical trials, including site selection, regulatory document preparation, and study material distribution.
• Collaborating with cross-functional teams to ensure alignment on study protocols, timelines, and operational requirements.
• Ensuring compliance with Good Clinical Practice (GCP) and other regulatory guidelines throughout the study setup phase.
• Providing ongoing support to study teams and sites, addressing any issues that arise during the trial setup process.
• Maintaining accurate records and documentation related to study setup activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level