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.
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 masters 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.
Our mission is to improve the health of millions of people worldwide.
- Full time Position
- Location – New Delhi
- Open Ended – Permanent
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 16 June 2024