Clinical Research Associate Job at iconplc (Reading)

Job Description

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. As a CRA you will be joining the world’s largest & most comprehensive clinical research organization, 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

Job Responsibility

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
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
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
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
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
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
Identifies issues at sites
resolves issues and escalate as appropriate
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
Negotiates investigator remuneration
prepares financial contracts between ICON and investigational sites and investigators
Ensures that payments are appropriately triggered to investigational sites

Requirements

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
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 we offer

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

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Clinical Research Associate

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