Clinical Research Associate (Study Monitor)
Clinical Research Associate (Study Monitor)
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Job Description
Position Summary
- Position Title: Clinical Research Associate (Study Monitor)
- Career Step: Intermediate
- Reporting Relationship: Project Manager
- Division: Project Operations UK Centre for Operations & Research
- Employment Duration: 2 years
- Employment Type: Full-time
- Start date: ASAP
- Salary: per annum (dependent on experience)
Please note: the successful candidate must have an existing and ongoing right to work in the UK and must be willing and able to travel to USA every 2-3 months.
Context of the Role
The Project Operations (PO) team works closely with our Researchers to ensure studies and projects are delivered.
The Role
The Clinical Research Associate (CRA) is required to assist the Project Manager with various tasks associated with running a large scale clinical trial. Generally the Clinical Research Associate performs all monitoring tasks required at study sites including source data verification safety reporting drug accountability and the maintenance of study documentation. The CRA provides regular study updates and monitoring visit reports to the project manager and updates clinical study tracking systems as necessary.
The CRA will join the Project Operations team with the UK and contribute to the Global Project Operations team.
Reporting Relationships
The Clinical Research Associate reports to a Project Manager within the Project Operations team. The Clinical Research Associate will also develop effective working relationships with the programs study site staff.
Duties and Key Responsibilities
Study Design
- Assist with the identification and selection of investigators to undertake the study
- Conduct feasibility assessments
- 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.
General
- Assist Project Manager with other study related activities such as organising study meetings and scheduling travel producing agendas and minutes for study-related meetings responding to protocol and data collection enquiries maintaining study documentation assisting in the preparation of budgetary and administrative documents and other tasks as required.
- Manage effective communication with the key stakeholders (including the Study Management Committee Principal Investigators Research Coordinators etc.).
As a Team Member
- 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 The Institutes organisational 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 Work Health and Safety legislation and operate in accordance with established Occupational Health and Safety practice and procedures at the Institute;
- Promote and contribute to a safe secure environment for staff and visitors.
Skills Knowledge and Experience
Essential
- Tertiary qualifications in a related science or health care discipline
- Previous monitoring experience working on CTIMPs within an academic CRO or pharmaceutical environment as a study monitor or clinical research associate
- Working knowledge of and ability to implement project activities in accordance with ICH/GCP and all applicable regulations and guidelines in the relevant regions.
- Sound understanding of medical terminology
- Working 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 problem-solving skills
- Strong focus on producing the highest quality of work and on ensuring optimum accuracy of outputs
Desirable
- Full international driving license
About The George Institute
The George Institute for Global Health was established in 1999 with a mission to improve the health of millions of people worldwide particularly underserved populations by challenging the status quo and using innovative approaches to prevent and treat the worlds biggest killers: non-communicable diseases and injury.
With offices in UK Australia India and China our 700 people support 245 active projects and clinical trials across 50 countries with 400 more staff across our social enterprises. We focus on the global health challenges that cause the greatest loss of life the greatest impairment of life quality and the most substantial economic burden particularly in resource-poor settings.
Together with our academic partners Imperial College London UNSW Sydney in Australia and Manipal Academy of Higher Education in India we work with a global network of collaborators undertaking clinical population and health systems research.
What we do
- Lead world-class large-scale clinical trials epidemiological studies and health systems research to transform treatments and healthcare delivery
- Look beyondsingle diseases across the life courseto identify patient-centred approaches to care that can be implemented at scale
- Develop low-cost innovative solutions to global unmet needs
- Drive our global impact through a program of research advocacy thought leadership and disruptive social entrepreneurship
For more information about The George Institute visit
How to apply
Please click on the apply button and attach your CV and a cover letter. Application deadline is 14 October 2025 at 11.59pm(BST). If you have any questions please contact .
Required Experience:
IC
Employment Type
Full-Time
