Job title: SCRA

Location:Guang Zhou

Department: Medical & Regulatory Dept.

Report to: HGUO

 

Purpose of this job:

To conduct clinical trials/studies in CRO to support company business objectives and to ensure trial/study conduction in accordance with scientific, regulatory and corporate quality requirements.

 

Area of responsibilities:

 

Main Tasks:

 

Duties and responsibilities which are subject to periodic updating include:

 

·          Overseeing the management and administration of all aspects of clinical trials/studies involved in each step of the clinical trial/study.

·          Assisting with preparation of protocols and other necessary documents required for trial approval by HA.

·          Preparing protocols and other necessary documents required for trial approval by EC and getting EC approval on time.

·          Monitoring and coordinating the clinical trial conduction in whole process by following GCP and SOP strictly.

·          Make monitoring plan, co-monitoring plan, budget and tracking plan and followed it during trial process.

·          Tracking progress, status and performance regularly, find current problems/issues and make appropriate action plans.

·          Coordinating and giving input to all activities including query resolution, site closure and collection of documentation required for clinical trial reports after trail end.

·          Ensuring but not limited to, IMPACT, EDC system for administration of clinical trials is updated in a timely and accurate manner in accordance with requirements.

·          Ensuring all SAEs/adverse drug reactions are reported and followed up in a timely manner according to internal relevant SOP

·          Maintaining, updating and archiving all clinical trial files on time.

·          Maintaining up to date knowledge of diabetes treatment, company products, and clinical trial conduction.

·          Being LTM for CDP trial when needed, keep close contact with IO CDC or HQ project team.

·          Being project leader when needed, coordinate and lead team members have regular project review meeting, ensure accuracy of meeting minutes.

·          Coaching CRA from technical point.

·          Any other responsibilities and duties which may be required from time to time.

Main customers:

Internal customers:

 

All the internal colleagues in CRO, especially MED, MKT & Sales colleagues. The clinical operation colleagues in headquarters, IOCDC & other affiliates.

 

External customers:

 

All the healthcare professionals, officials. Especially the investigators in the clinical trials.

 

Education and Experience Requirements of the Position:

 

1.       Bachelor’s degree or above of Medical Science.

2.       Rich working experience in conducting clinical trials.

3.     Fluency English on both written & verbal.