Job Description

Job ID 251251BR
Position Title Clinical Research Associate
Job Description 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.
- Conduct site selection for potential sites to evaluate their capabilities for conducting a clinical trial. Recommend sites to participate in clinical trial
 - Be the frontline liaison between Novartis and sites to ensure successful collaboration, meeting Novartis expectation on milestone and deliveries
 - Manage assigned study sites and networks, if applicable, conducting phase I-IV protocols according to the monitoring plan and Novartis 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
 - Be 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
 - Documents monitoring activities appropriately following Novartis standards
 - Collaborate with the CRA Manager/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 ensure implementation of corrective actions within specified timelines
 - Perform additional task as assigned
 - Monitor studies as per current legislations, ICH/GCP and Novartis standards
 - Ensure timely delivery, high quality, robust and reliable data of the monitored sites to support the goals of Trial Monitoring as defined by Trial Monitoring. (ADIS, DBL)
 - Identify issues at sites; resolves issues and escalate as appropriate
 - Collaborate with internal stakeholders and site personnel to manage data query resolution process to ensure timely and accurate data entry
 - Ensure the site Investigator Folder is up to date. Be responsible for collecting essential documents from site and accountable to keep sTMF(s) current.
 - Support the implementation of innovative processes and technologies
 - Negotiate investigator remuneration; prepare financial contracts between Novartis and investigational sites and investigators. Ensure that payments are appropriately triggered to investigational sites
Minimum requirements A degree in a scientific or health care discipline preferred. Relevant experience on exception only. Fluent in both written and spoken English, local language as needed in clusters/countries. •Up to 2 years pharmaceutical industry experience or other relevant experience

More Jobs at Novartis Follow Company

See all jobs at Novartis