Clinical Research Associate - 12 months' monitoring experience required

Senior CRA

Icon plc is a world leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

Role

Location: Must be based in the UK, ideally in the Midlands or South West of the UK (nationwide travel).
Duration: 12+ months' monitoring experience required.

Fully sponsor dedicated

As a Clinical Research Associate, you will be dedicated to one of our global pharmaceutical clients - a science based company with an exciting product pipeline in oncology, general medicine and eye care. You will build your career in a customer focused environment that supports creativity, collaboration and performance.

Your responsibilities include, but are not limited to:

• Lead site selection and site initiation visits, ensuring site personnel is fully trained on all trial aspects.
• Manage assigned study sites and networks, conducting phase I IV protocols according to the monitoring plan and client procedures.
• Perform continuous training for amendments and new site personnel; retrain site personnel as required.
• Conduct continuous monitoring activities (onsite and remote) to ensure compliance with protocol, GCP, global and local regulations, and client processes.
• Ensure that study milestones for sites (startup, recruitment, database analyses, closeout) are met as planned.
• Perform site closeout activities per SOPs and applicable regulations, ensuring archiving requirements are met.
• Document monitoring activities appropriately following Icon standards.
• Participate in audit organization and inspection readiness activities and implement corrective actions within specified timelines.
• Identify issues at sites, resolve and, if appropriate, elevate them; collaborate with stakeholders to manage data query resolution.
• Maintain the site Investigator Folder and ensure essential documents are current.
• Negotiate investigator remuneration; prepare financial contracts and trigger payments appropriately.

You will need the following:

• Right to work in the UK.
• Up to 2 years pharmaceutical industry experience or other relevant experience (NHS or Academic).
• Good knowledge of the drug development process, specifically clinical trial/research.
• Knowledge of international standards (GCP/ICH, FDA, EMEA).
• 12+ months' monitoring experience required.
• Ability to travel domestically (and possibly internationally) as needed.
• Minimum of 50% overnight travel may be required.

What Icon can offer you:

We offer competitive salary and a range of benefits designed to be competitive within each country and focused on well being and work life balance.

• Various annual leave entitlements.
• Health insurance offerings to suit you and your family's needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence.
• Global Employee Assistance Programme, LifeWorks, offering 24 hour access to a global network of over 80,000 specialists supporting you and your family's well being.
• Life assurance.
• Flexible country specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

Visit our careers website to read more about the benefits of working at Icon:

Equal Employment Opportunity

At Icon, diversity, inclusion & belonging are fundamental to our culture and values. We are a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process or to perform essential functions of the position, please let us know through the form at

Apply

We encourage you to apply regardless of whether you meet every requirement; we are always looking for new talent to join Icon. If you are a current Icon employee, please click here to apply.