Clinical Research Associate
The George Institute For Global Health
Location
Secunderabad | India
Job description
Study Design:
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 (e.g. 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 efficient 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 Institute's Performance Management and Development Policy;
- Demonstrate commitment to GI's values, including performing to an exceptionally high ethical standard and focus on integrity, collaboration and teamwork in all efforts.
Work, Health and Safety
- Comply with GI's Work Health and Safety Policy and related procedures, and similar policies which apply when visiting the premises of affiliates and collaborating sites.
- Promote and contribute to a safe, secure environment for staff and visitors.
Skills, Knowledge and Experience
- Qualifications: Bachelors/ Masters in basic life sciences
- Tertiary qualifications in a related science or health care discipline
- Previous onsite and remote monitoring experience working on clinical projects within an academic, CRO or pharmaceutical environment.
- Working knowledge of, and ability to implement project activities in accordance with, ICH/GCP and all applicable regulations and guidelines in the relevant regions.
- Basic understanding of medical terminology
- Knowledge of ICH/ GCP guidelines
- Understanding of confidentiality and privacy laws and all guidelines relevant to medical research
- Excellent skills in MS Office applications including Excel and Word
- Excellent interpersonal skills and the ability to work well and flexibly i.e. autonomously, in small teams and with a wide range of varying stakeholders
- Strong focus on producing the highest quality of work and on ensuring optimum accuracy of outputs
- Ability and willingness to travel.
- Demonstrated capability to produce outcomes and achieve objectives within agreed time periods;
- Strong problem solving, analytical skills, and proven strategic thinking;
- Ability to demonstrate flexibility and to be adaptable to changing organisational priorities and ambiguous environments;
- Well organised and efficient, with the capacity to work under pressure;
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Salary