Clinical Research Associate (CRA)
Business Unit Manager
+32 497 71 58 10
Description de l'emploi
The CRA performs monitoring activities related to initiation, conduct (recruitment, quality data collection) and timely completion of Phase I-IV Oncology and Pharma clinical trials within the country.
The CRA is responsible to deliver data within timelines and required quality standard, responsible for adherence to monitoring procedures in accordance with GCP and ICH, local regulations and SOPs.
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 the company and sites to ensure successful collaboration, meeting the company's expectation on milestone and deliveries
- Manages assigned study sites and networks, if applicable, conducting phase I-IV protocols according to the monitoring plan and 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 the 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 company 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
- Degree in scientific or healthcare discipline.
- Fluent in both written and spoken English, local language as needed in clusters/countries.
- Min 2 years pharmaceutical industry experience or other relevant experience
- Good knowledge of drug development process specifically clinical trial/research
- Knowledge of international standards (GCP/ICH, FDA, EMEA)
- Monitoring experience is required