The George Institute For Global Health
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Clinical Research Associate

Type of career: 
Jobs
Country: 
China
City: 
Beijing
Application close date: 
30/09/2017
Contact name: 
Danting ZHANG

 

 

The Role

The Clinical Research Associate (CRA) is a member in Diabetes Research Program. The CRA involves in the study preparation, planning, implementation, conduct site visits, follow up the clinical academic study in Diabetes Research to ensure it adheres to regulatory and ethical standards and deliver the study within timeline.  

Reporting Relationships
The Clinical Research Associate functionally reports to the Project Manager for project specific responsibilities. The position may be mentored and guided by Senior Clinical Research Associates. The position may also direct tasks of an allocated Clinical Trials Assistant. The Clinical Research Associate will be instrumental in developing effective working relationships with the program’s study site staff.

Duties and Key Responsibilities

Study Design
• Coordinate the identification, feasibility assessment and selection of investigators and sites to undertake the study
• Prepare, plan, organise and conduct pre-study (site selection) visits and report on these visits to assist in site selection
• Prepare for, plan, organise and conduct site initiation visits
• Assist in the development of appropriate monitoring tools
• Motivate and train investigators and ensure that the study site personnel have a good understanding of the protocol, and the requirements of the study and that they can fulfil their obligations to conduct the study accurately and to deadlines.
Study Execution
• Motivate investigators and ensure that the study site personnel enrol the target number of eligible subjects within timeline
• Monitor study by visit, email and telephone to the participating centres to ensure:
• Verify quality, completion, and timeliness of data.
• Completely and efficiently resolve data and audits queries and issues.
• Adhere to the study protocol and study procedures manual.
• Adhere to ICH/GCP and other regulatory guidelines and requirements as relevant to this trial including reporting of adverse events/serious adverse events are reported
• Complete all monitoring visit and progress reports accurately and within the predetermined timeframe.
• Collect and review essential documents from study sites and ensure they are appropriately stored/managed in-house.
• Assist participating centre research staff in the local management of the study where required.
• Maintain study information using the clinical trial management system.
General
• Manage effective communication with the key stakeholders (outside vendors, Research Coordinators, etc).

As a Team Member:
• Participate in team meetings and activities
• Participate in objective setting and performance management
• Participate in special projects to improve processes, tools, systems and organization of GI China

Occupational Health and Safety
• Comply with OH&S legislation and operate in accordance with established OH&S practice and procedures at The George Institute
• Promote and contribute to a safe, secure environment for staff and visitors

 

Skills, Knowledge, and Experience

Education/ Research Background
• Tertiary qualifications in a related science or health care discipline, research background with post-graduate qualifications preferred.
• 2 years experience in clinical operation within an academic, CRO or pharmaceutical environment.
• Understanding of medical terminology
• Excellent working knowledge of ICH/GCP, ethical and regulatory requirements
• Excellent interpersonal skills, presentation skills and the ability to work well and flexibly ie autonomously, in  teams and with a wide range of varying stakeholders
• Excellent organisational skills – ability to organise, take initiative and follow up independently
General
• Excellent interpersonal skills, presentation skills and the ability to work well and flexibly ie autonomously, in  teams and with a wide range of varying stakeholders
• Excellent organisational skills – ability to organise, take initiative and follow up independently, Familiarity with computer systems particularly MS Word, PowerPoint & Excel
• Ability and willingness to travel on a regular basis
• Ability to see the big picture, yet still focus on detail and quality of work
• Ability to be flexible and adaptable in the face of changing organisational priorities and ambiguous environments.