The Clinical Research Associate would be expected to:
- Assist with the identification and selection of investigators to undertake the study
- Conduct feasibility assessment
- Assist in the preparation of documentation for ethics submission
- Create, organise and collate documents required by the project team prior to the start of the study (eg protocols, questionnaires, feasibility, confidentiality agreements, etc)
- Assist in the development of appropriate monitoring tools
- Organise and participate in investigator meetings
- 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
- Collect and review essential documents from study sites
- Motivate and train investigators
*Study Execution:*
- Perform study monitoring by visit, email and telephone to the participating centres to ensure:
- Data quality, accuracy, completeness and timeliness of data completion
- Complete and productive resolution of data queries
- Adherence to the study protocol and study procedures manual
- Adherence to ICH/GCP and other guidelines and requirements as relevant to this trial
- Complete monitoring visit reports accurately and within the predetermined timeframe
- Coordinate distribution, tracking, handling and destruction of study supplies per site
- Assist participating centre research staff in the local management of the study where required
*The Clinical Research Associate should also:*
As a Team Member:
- Participate in team meetings and activities relating to assigned project(s) and own work area;
- Participate in special projects to improve processes, tools, systems and organisation;
- Take responsibility for personal learning and development and for setting achievable and meaningful work objectives and managing personal targets, meeting obligations of the Institutes Performance Management and Development Policy;
- Demonstrate co
📌 Clinical Research Associate (Hyderabad)
🏢 The George Institute for Global Health
📍 Hyderabad
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