About this role

  • Posted on

  • Location

    England

  • Salary

    £45000.00 - £54000.00 per annum

  • Type

    Permanent

  • Division

    Clinical Operations Jobs

  • Reference

    BBBH18635_1625039774

  • Start date

    ASAP

  • Managing this role

Executive Consultant

Jon Martin

+44 203 8540 262

jon.martin@xplorelifescience.com

154-158 Shoreditch High Street, E1 6HU

Description

My client, a well-established global CRO is actively seeking an experienced Senior Clinical Research Associate to join on a permanent basis to be based remotely in the UK. As a Senior Clinical Research Associate at you’ll work within a large-scale, fast-paced environment alongside a close-knit team of highly qualified CRAs to identify, select, initiate, and close-out investigational sites for clinical studies in phases I – IV, ensuring adherence to applicable regulations and principles of ICH-GCP.

The Senior Clinical Research Associate is the clinical sites’ direct point of contact and accountable for managing site quality and delivery from site identification through close-out. The aim of this role is to build the relationship with the site, to be the sole position accountable for the site performance, including driving the site successfully to the initiation, the development of a robust patient recruitment strategy, setting up a system, assessing compliance with regulations and the site’s capability to comply with the study needs and recruitment expectations, and problem-solving to address and resolve site issues.

The Role

  • Build relationships with investigators and site staff.
  • Facilitate and support sites with access to relevant study systems and ensure sites are compliant with project-specific training requirements.
  • Independent, proactive work to set up and monitor studies, complete reports, and maintain documentation
  • Submitting protocol, consent documents for ethics/IRB approval, as well as preparing regulatory submissions
  • Balancing sponsor generated queries
  • Taking responsibility for study cost-efficiency
  • Preparation and review of study documentation and feasibility studies for new proposals
  • Potential to assist in training and mentoring fellow CRAs

What you need

  • 3 years+ of monitoring experience in phase I-III trials as a CRA
  • Minimum of a Bachelors degree in medicine, science, or equivalent
  • Oncology experience ideally
  • Previous monitoring experience in medium-sized studies, including study start-up and close-out
  • Knowledge of ICH-GCP guidelines and ability to review and evaluate medical data
  • Excellent written and verbal communication
  • Ability to work to tight deadlines
  • Availability to travel locally and should possess a valid driving license
  • Willingness to travel 1.5-2 days a week to any UK location or region

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