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 peoples 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:
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 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 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 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 are:
Degree in scientific or healthcare discipline.
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)
Monitoring experience is desirable
Lifelancer (https://lifelancer.com) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech, data science and IT domains.
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