The Senior 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.
Trial Monitoring strategy
Conducts feasibility and screen potential Investigators and networks to evaluate capabilities for conducting clinical trials
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
• Manages assigned study sites and networks, if applicable, conducting phase I-IV protocols according to the monitoring plan and procedures
• Facilitates the preparation and collection of site and country level documents
• 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 Client 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
• Monitors studies as per current legislations, ICH/GCP
• 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.
• Participates in multi-disciplinary teams within CPO and globally to evaluate and implement process improvement
• Supports the implementation of innovative processes and technologies
- Degree in scientific or healthcare discipline.
• Minimum of 3 years experience in site monitoring
• Excellent knowledge of the drug development process specifically clinical trial/research
• Knowledge of international standards (GCP/ICH, FDA, EMEA)
• Ability to manage multiple priorities and manage time efficiently.
• Basic project management skills
Source: Job Diva – Job Listing