Clinical Research Associate (CRA)-Excl. IT Costs

CRA - Oncology experience required

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: Clinical Research Associate (CRO and/or Pharma monitoring and Oncology experience required)

Location: Must be based in the UK, nationwide travel

Fully sponsor dedicated

As a CRA you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

As Clinical Research Associate, you will be dedicated to one of our global enterprises who are focused on healthcare and agriculture. It develops and markets pharmaceuticals, consumer health products, crop protection solutions, seeds, and digital farming technologies.

Responsibilities

• Conduct site selection for potential sites to evaluate their capabilities for conducting a clinical trial. Recommend sites to participate in clinical trial. Act as the frontline liaison between ICON and sites to ensure successful collaboration, meeting ICON expectations on milestones and deliveries.
• Manage assigned study sites and networks, conducting phase I-IV protocols according to the monitoring plan and client procedures. Perform Site Initiation Visit, ensure site personnel is fully trained on all trial related aspects. Provide continuous training for amendments and new site personnel as required.
• Conduct continuous monitoring activities (onsite and remote). Implement site management activities to ensure compliance with protocol, GCP, global and local regulations, and processes to secure data integrity and patient safety. Continuously update all electronic systems relevant to perform job functions.
• Ensure that study milestones for sites are met - startup, recruitment, database analyses, closeout, etc. Perform Site Closeout activities per SOPs and applicable regulations to ensure follow up activity and archiving requirements. Attend onboarding-, disease indication and project specific training and general CRA training as required.
• Document monitoring activities appropriately following ICON standards. Collaborate with the CRA Group Head/CSM to ensure recruitment plans and execute contingency plans as needed.
• Participate in audit organization and inspection readiness activities for monitoring and site related activities as required and ensure implementation of corrective actions within specified timelines.
• Perform additional tasks as assigned to deliver quality data and compliance to quality standards.
• Monitor studies as per current legislations, ICH/GCP and client standards. Ensure timely delivery of high quality, robust and reliable data. Identify issues at sites; resolve issues and escape as appropriate.
• Collaborate with internal stakeholders and site personnel to manage data query resolution process to ensure timely and accurate data entry. Keep the Investigator Folder up to date and maintain essential documents from site and accountable to keep sTMF(s) current. Support implementation of innovative processes and technologies and budget and productivity.
• Negotiate investigator remuneration; prepare financial contracts between ICON and investigational sites and investigators. Ensure payments are appropriately triggered to investigational sites.

Qualifications

• Right to work in the UK.
• Up to 2 years pharmaceutical/CRO industry experience.
• Good knowledge of drug development process specifically clinical trial/research.
• Knowledge of international standards (GCP/ICH, FDA, EMEA).
• 12+ months monitoring experience required.

Important for the role

• Ability to travel domestically (and possibly internationally) as needed to study sites and for training and meetings.
• Minimum of 50% overnight travel may be required.

What ICON can offer you

Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well being and work life balance opportunities for you and your family.

• Various annual leave entitlements.
• A range of health insurance offerings to suit you and your family's needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, TELUS Health, offering 24 hour access to a global network of over 80,000 independent specialised professionals who are there to support 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:

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation. We're dedicated to providing an inclusive and accessible environment for all candidates.

ICON is committed to providing 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 in order to perform the essential functions of a position, please let us know through the form below.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply.