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 (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 effective 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 commitment to GIs 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 GIs 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 ie 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;

Disclaimer: This has been sourced from a public domain and may have been modified by Naukri.com to improve clarity for our users. We encourage job seekers to verify all details directly with the employer via their official channels before applying.

📌 Clinical Research Associate (Hyderabad)
🏢 The George Institute for Global Health
📍 Hyderabad