Regional Trainer

[Megan Tan]

Description

To provide structured & consistent training for members of Medical Department in Asia OPUs and also specific systems / quality training for CRO CRAs conducting trials

Job Role

• Function as a dedicated training contact, consultant and support for members of Medical Department in Asia OPUs. Together with the local & regional management, define the individual training needs of the local associates [CRA / CML / RPM / CRM / CSO / DRA / MA]
• Ensure that national and international GCP regulations and guidelines, company Global SOPs/WIs, Quality Assurance Practices are disseminated to and fully understood and followed by the appropriate personnel within the Medical Dept Asia
• Ensure the required level of quality for all new medical staff by providing mandatory foundational training on all GCP / SOPs / WIs & systems
• Support Medical Dept staff with the required training / updates to meet international standards of compliance via numerous training methods / programs
• Serve as a resource person for questions relating to GCP, global SOPs & medical systems. Ensure that staff’s knowledge reflects the most recent developments in the field of good clinical research practice & system developments
• Be able to deliver training on the following scenarios where experience is adequate and identify trainers locally as necessary to deliver other relevant topics
• Management & organization of Regional Training Events, working with the various Medical Depts [Clinical Research, Drug Safety, DRA & Medical Affairs] to ensure training needs & objectives are met
• For events where external trainers are required, select appropriate vendors, negotiate contract and supervise the implementation as per contractual agreement.
• Ensure competence of external CRO staff working on company trials by conducting trainings on mandatory systems & SOPs on a reliable & consistent basis with an efficient tracking system Global point of contact in the implementation of global initiatives, communicate with International Training Committee to continuously improve the function in Asia.
• Ensure a standard and comprehensive central training record system is available in all OPUs for their members recording training done
• Provide RDC & SOP trainings to contracted CRO staff on a monthly basis
• Provide GCP training to Investigators & study coordinators on a trial specific basis

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