Clinical Research Associate (CRA)

Our mission is to improve the health of millions of people worldwide.

• Full time Position
• Location - New Delhi / Hyderabad / Remote 
• Fixed Term – One year

We have an opportunity for your career to make a difference!  We have a new and exciting opportunity for a Clinical Research Associate (CRA) to join our organisation.

 How to apply:
Interested candidates should send their resume with full contact details, current and expected CTC/salary. Clearly mentioning the job title "Clinical Research Associate (CRA)" in the subject line to hrindia@georgeinstitute.org.in by the 12 February 2024

Context and Role 

Non-communicable diseases (NCDs) cause over 70% of all deaths worldwide each year. 85% of premature deaths due to NCDs are in low- and middle-income countries. The George Institute is focused on finding better treatments for the world’s biggest health problems including renal and cardiovascular diseases.

We are conducting large-scale clinical trials, often across multiple countries and clinical sites, and developing new medicine and technology solutions to prevent and treat common chronic and critical conditions with a global perspective.

Our work is transforming practice and improving health outcomes worldwide. A Clinical Research Associate (CRA) will work on trials testing new and existing drugs and will typically be involved in all stages of the clinical trial, including identifying an investigational site and setting up, initiating, monitoring and closing down the trial.

Reporting Relationships

Directly reports to the Project Manager

Duties and Key Responsibilities

The Clinical Research Associate would be expected to:

• Assist in the development of trial related documents including but not limited to the protocol, investigator’s brochure, patient information documents and care report forms.
• Coordinate with the ethics committee, which safeguards the rights, safety and wellbeing of all trial subjects.
• Assist in regulatory authority applications and approvals that oversee the research and marketing of new and existing drugs.
• Assess the suitability of facilities to use as the clinical trial site.
• Assist in the selection of an investigator who will be responsible for conducting the trial at the trial site.
• Liaise with doctors, consultants or investigators on conducting the trial.
• Set up the trial sites - ensuring each centre has the trial materials, including the trial drug often known as the investigational medicinal product (IMP)
• Train the site staff to trial-specific standards.
• Monitor the trial throughout its duration, which involves visiting the trial sites on a regular basis and dealing with and solving any issues
• Verify that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV)
• Collect completed CRFs from hospitals and general practices
• Write visit reports and file and collate trial documentation and reports
• Meet with team members to discuss on-going trials, results and any trends or adverse events
• Ensure all unused trial supplies are accounted for
• Close down trial sites on completion of the trial
• Archive study documentation and correspondence
• Prepare final reports for sponsors, regulatory authorities, and ethics committees

As a Team Member:

• Participate in team meetings and activities relating to the TRACK trial 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 in life sciences, medical sciences or nursing with master's degree in clinical research.
• Experience of at least 2 years as a clinical research coordinator or 1 year as a clinical research associate.
• Demonstrated experience in working with electronic data capture tools such as REDCap, OpenClinica, Zelta etc.
• Willingness to travel to conduct frequent site monitoring visits.
• Demonstrated capability to produce outcomes and achieve objectives within agreed time periods.
• Strong problem solving, analytical skills, and proven strategic thinking.
• Demonstrated resourcefulness, with ability to influence others to achieve common goals.
• Excellent interpersonal skills with high level of proficiency in English and the ability to work well autonomously.
• Excellent team-workskills, with demonstrated ability to collaborate in small teams and with a wide range of varying stakeholders.
• Ability to demonstrate flexibility and to be adaptable to changing organisational priorities and ambiguous environments.
• Strong focus on producing the highest quality of work and on ensuring optimum accuracy of outputs.
• Well organised and efficient, with the capacity to work under pressure.

For more details, please see the Position Description for this role.

The George Institute India

The George Institute, a wholly owned legal not-for-profit Indian research institute, has been conducting research related activities in India since 2002. The George Institute India’s mission mirrors that of the parent organization, namely the discovery and implementation of solutions to chronic and disabling health problems through research, policy development and capacity building.

A number of large-scale projects in population, health systems and clinical research, funded by a diverse group of sponsors, both public and private, are conducted in India. The George Institute India comprises two distinct operating groups: Research and Development, and Infrastructure and Resources. It has two separate offices - in Hyderabad and New Delhi, where the research staff and senior management are based. 

About the George Institute

We are a medical and health research institute affiliated with leading universities aiming to challenge the status quo in health care. With 700+ people around the world, and projects in over 40 countries, our Strategy 2025 is all about impact – specifically, the impact of The George Institute’s activities on the health of millions of people, particularly those living in disadvantaged circumstances around the world.

Our strategy focuses on three key research priorities:

• Better Treatments: finding better treatments for the world’s biggest health problems
• Better Care: transforming primary health care to support better health for more people
• Healthier Societies: harnessing the power of communities, governments and markets to improve health

For more information about The George Institute, visit www.georgeinstitute.org.