Clinical Research Associate - 12+ months' monitoring experience required

Role: Clinical Research Associate (12+ months' monitoring experience required) 

Location: must be based in Ireland

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 pharmaceutical clients; a science-based company with one of the most exciting product pipelines in the industry. This global pharmaceutical client develops breakthrough innovative medicines to improve and extend people’s lives in oncology, general medicine and eye care. Working in this way, you will have the opportunity to build your career in a rewarding customer-focused environment that supports creativity, collaboration and performance.

Your responsibilities include, but are not limited to: Allocation, initiation and conduct of trials:

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  Conducts site selection for potential sites to evaluate their capabilities for conducting a clinical trial. Recommends sites to participate in clinical trial. Is the frontline liaison between ICON and sites to ensure successful collaboration, meeting ICON expectation on milestone and deliveries
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  Manages assigned study sites and networks, if applicable, conducting phase I-IV protocols according to the monitoring plan and our clients procedures. Performs Site Initiation Visit, ensures site personnel is fully trained on all trial related aspects. Performs continuous training for amendments and new site personnel as required. Retrains site personnel as appropriate.
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  Conducts continuous monitoring activities (onsite and remote). Implements site management activities to ensure compliance with protocol, GCP, global and local regulations, global and local processes to secure data integrity and patient safety. Is accountable for continuously updating all electronic systems (global and local) relevant to perform job functions.
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  Ensures that study milestones for sites responsible are met as planned (i.e., study startup, recruitment, database analyses, closeout, etc.). Performs Site Closeout activities per SOPs and applicable regulations to ensure that site is aware of any follow up activity and archiving requirements. Attends onboarding-, disease indication and project specific training and general CRA training as required
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  Documents monitoring activities appropriately following ICON standards. Collaborates with the CRA Group Head/CSM to ensure recruitment plans and execute contingency plans,as needed. Participates from audit organization and inspection readiness activities for monitoring and site related activities as required and ensures implementation of corrective actions within specified timelines. Performs additional task as assigned Delivery of quality data and compliance to quality standards
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  Monitors studies as per current legislations, ICH/GCP and our clients standards. Ensures timely delivery, of high quality, robust and reliable data of the monitored sites to support the goals of Trial Monitoring as defined by Trial Monitoring. (ADIS, DBL). Identifies issues at sites; resolves issues and escalate as appropriate
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  Collaborates with internal stakeholders and site personnel to manage data query resolution process to ensure timely and accurate data entry. Ensures the site Investigator Folder is up to date. Is responsible for collecting essential documents from site and accountable to keep sTMF(s) current. Supports the implementation of innovative processes and technologies Budget and productivity
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  Negotiates investigator remuneration; prepares financial contracts between ICON and investigational sites and investigators. Ensures that payments are appropriately triggered to investigational sites.

You will need the following:

• Right to work in Ireland and Northern Ireland
• Up to 2 years pharmaceutical industry experience or other relevant experience (NHS or Academic)  
• 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.
  
• A 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.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximise 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: https://careers.iconplc.com/benefits

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.

https://careers.iconplc.com/reasonable-accommodations

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.