Clinical Research Associate/Clinical Research Officer
About The George Institute
We are a medical 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.
Context and Role
We are seeking Clinical Research Associate/Clinical Research Officer to support the academic investigators in managing clinical operations of the investigators initiated academic trials conducted by TGI,India The Clinical Research Associate/Clinical Research Officer is required to assist the Program Head with various tasks associated with running a large-scale clinical trial. Generally, the CRO performs all monitoring tasks required at study sites, including source data verification, safety reporting, drug accountability and the maintenance of study documentation. The CRO provides regular study updates and monitoring visit reports to the project manager and updates clinical study tracking systems as necessary.
The Clinical Research Officer reports to the Program Head at TGI India. The Clinical Research Officer will also develop effective working relationships with the projects’ study site staff.
Duties and Key Responsibilities
The Clinical Research Officer 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
- 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/Clinical Research Officer 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;
Reporting To: Program Head
Fixed term (Duration): Fixed term (two year)
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/Clinical Research Officer in the subject line to firstname.lastname@example.org by the 10-Nov-2021
Our big and bold mission to improve the health of millions of people worldwide needs a diverse and innovative team to deliver it. So, we foster a dynamic, inclusive and flexible workplace where each individual can bring their best selves to work.
Everyone is encouraged to apply, including people from culturally and linguistically diverse backgrounds, people with a disability, people of all gender identities and sexual orientations, and mature-aged adults.
Type of career: Jobs
Application close date: 10/11/2021