What if your clinical operations expertise helped new medicines take their first step in human clinical trials

Fortrea is one of the largest and longestestablished earlystage clinical research organizations in the world.

We operate four Phase I clinical research units globally including our worldclass Leeds clinic. Just a 7minute walk from the train station it is one of the few MHRAaccredited Phase I units in the UK.

If Fortreas Leeds Phase I unit is where lifesaving medicines begin their journey this job exists to transform complex study plans into safe and coordinated Phase I-Ib clinical delivery.

This is a fulltime permanent role based on site at Fortreas Drapers Yard Clinical Research Unit in Leeds:

• You will work 37 hours per week typically Monday to Friday.
• As with most Phase I clinical research environments there may be occasional additional hours or weekend work depending on study timelines or clinic needs.
• Any additional time worked is compensated with flex time in line with site practice.

IN THIS ROLE YOU WILL

As our next Clinical Research Coordinator you will help multidisciplinary teams stay aligned during study setup and live trial activity acting as the operational link between protocol intent and what actually happens on the clinic floor.

In practice this means you will:

• Coordinate study setup activities from study award through site readiness supporting the creation review and alignment of study documentation schedules and operational plans.
• Act as a central point of coordination during live studies supporting critical study moments such as participant checkin dosing days and closeout and escalating issues as needed.
• Work closely with principal investigators clinical laboratory pharmacy and screening teams to ensure activities are delivered in line with approved protocols SOPs and timelines.
• Support study documentation quality and oversight including protocol review participantfacing documents site files or EC submission packages ensuring they remain accurate complete and auditready.
• Maintain regular communication with investigators and project teams providing operational insight and updates throughout the life of a study.

QUALIFICATIONS/ EXPERIENCE

• University/college degree in life science pharmacy or related subject or certification in a related allied health profession (e.g. nursing).
• In lieu of a degree typically 3 years experience in a related field will be considered.

To succeed in this job you will bring:

• Typically a minimum of 3 - 4 years experience supporting or coordinating clinical trials. Backgrounds that translate well into this role include: CRAs looking to stop travelling Study Coordinators Site-based Clinical Operations roles etc.

• Practical knowledge of clinical trial protocols including an understanding of study objectives study design and study procedures and how these translate into sitelevel execution.
  
• A solid understanding of the drug development process with working knowledge of ICH guidelines and Good Clinical Practice (GCP)

• Experience managing multiple studies or workstreams in parallel remaining organised and effective in a fastpaced live clinical research environment.

• Direct involvement in study set-up and live study activity contributing to site readiness activities and supporting studies during active clinical conduct.

• Strong written communication skills in English particularly when working with clinical documentation and protocoldriven materials.

If you want a job where your daytoday decisions influence whether new medicines are ready to progress to the next stage of development apply now to join Fortreas Leeds Phase I clinic.

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