Clinical Research Associate - Oncology

Clinical Research Associate - Oncology experience required

2 days ago Be among the first 25 applicants

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 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.

Your responsibilities include, but are not limited to:

• Conduct site selection for potential sites to evaluate their capabilities for conducting a clinical trial. Recommend 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.
• Manage assigned study sites and networks, if applicable, conducting phase I-IV protocols according to the monitoring plan and our clients procedures. Perform Site Initiation Visit, ensure site personnel is fully trained on all trial related aspects. Perform continuous training for amendments and new site personnel as required. Retrain site personnel as appropriate.
• Conduct continuous monitoring activities (onsite and remote). Implement 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.
• Ensure that study milestones for sites responsible are met as planned (i.e., study startup, recruitment, database analyses, closeout, etc.). Perform Site Closeout activities per SOPs and applicable regulations to ensure that site is aware of any 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 from audit organization and inspection readiness activities for monitoring and site related activities as required and ensures implementation of corrective actions within specified timelines.
• Perform additional task as assigned Delivery of quality data and compliance to quality standards.
• 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 escalation as appropriate.
• Collaborate 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.
• Negotiates investigator remuneration; prepares financial contracts between ICON and investigational sites and investigators. Ensures that payments are appropriately triggered to investigational sites.

You Must Have The Following:

• 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…