Site Start-Up Specialist

Role overview

Fortrea is looking for a Site Start-Up Specialist to support the smooth launch and ongoing setup of clinical research sites. In this position, you will help coordinate start-up activities, manage critical study documents, and keep regulatory submissions moving on schedule so that clinical trials can advance efficiently and in compliance with requirements. The role sits within the FSPx team and involves direct support for one of Fortrea’s key sponsor partners, contributing to the development of innovative treatments that can reach patients sooner.

Key responsibilities

• Act as the main point of contact for investigative sites throughout start-up and maintenance phases.
• Gather, check, and arrange essential documents needed for submissions to EC, IRB, third bodies, and regulatory authorities.
• Maintain adherence to ICH/GCP standards, applicable regulations, and sponsor-specific expectations.
• Draft and file regulatory materials, including country-level application documents and informed consent forms.
• Monitor submission deadlines and take action early when timelines are at risk.
• Work closely with internal teams, external partners, vendors, clinical functions, and regulatory agencies.
• Keep study records complete, inspection-ready, and updated across relevant systems.
• Support site contract and budget discussions where required.
• Guide and coach new team members and colleagues with less experience.

Requirements

• A university or college qualification, preferably in life sciences, or a certification in an allied health discipline.
• At least 2 years of experience in clinical research, site activation, or regulatory submissions.
• Good working knowledge of ICH/GCP, RA, IRB/IEC rules, and start-up procedures.
• Ability to review and tailor patient informed consent forms for local and protocol-specific needs.
• Hands-on experience working with regulatory authorities and site start-up teams.
• Strong planning, communication, and problem-solving abilities.
• Comfort using Microsoft Office and document management platforms.
• Fortrea may accept equivalent relevant experience in place of formal education.

What we offer

You can expect competitive pay with performance-linked incentives, flexibility through remote or hybrid working arrangements, and chances to grow professionally in a collaborative, forward-thinking environment. This role also offers exposure to advanced clinical research programs.

Additional information

Applications are reviewed continuously on a rolling basis, so interested candidates are encouraged to submit their application without delay. An equal employment opportunity and accommodations request note is included in the source information.