Need to have a valid UK driving license and a car
Job Title: Clinical Research Associate
Location: Witney, Oxfordshire
Salary: £42,000 - £48,000 per annum (Depending on your experience)
Position Type: 12 Months
Work mode: Onsite
This position is on-site and involves traveling across the UK. On days when you are not traveling, you will be based at the Witney site.
Please note that this role requires a valid UK driving license and access to a car. Additionally, candidates must be willing to travel as needed.
Work experience
- The role of the Clinical Research Associate (CRA) sits within the Clinical Affairs team. The Clinical Affairs team provides the clinical investigation support required for R&D, Worldwide Marketing, UK and US Operations, and QARA. This includes a post-market surveillance performance monitoring programme for all ADC products and complaint investigations
The primary functions of the CRA role are:
- Day-to-day management of the conduct of clinical investigations at study sites as a representative of the ADC Clinical Affairs team
- Monitoring to ensure studies are conducted according to protocols, applicable ADC procedures, GCP and all applicable regulations, and to ensure that subject safety and data integrity are maintained
- Support cross-functional projects and liaise with other groups across Abbott. Provide input into new product development projects, execute clinical activities to progress both studies and projects
- Conduct site visits and study monitoring to ensure all clinical studies meet procedural and GCP requirements
- Prepare monitoring reports
- Prepare study documentation and study files
- Support ethics and regulatory submissions
- Support conduct of site initiation visits
- Support training of investigators and site study teams
- Support all aspects of study delivery at a site-level
- Maintain good relationships with all investigators and study teams. Identify study/site issues and propose solutions
- Provide input into clinical study protocols/clinical investigation plans
- Maintain the effectiveness of the Abbott Quality System and be responsible for compliance with applicable regulations, standards and Corporate/Divisional policies
- Address corrective actions and audit observations in a timely manner
- Identify, propose and implement changes to policy, process and/or procedures as appropriate
- Facilitate and maintain communications with US Clinical Affairs, UK R&D, Operations and QARA
- Present study procedures to doctors and nurses at study sites
- Comply with EHS regulations and Abbott standards, initiatives and procedures, be accountable for the health and safety of themselves and others and by highlighting where improvements to EHS performance can be made
- Liaise with external personnel in a professional manner
- Represent ADC at external meetings and conferences
- Perform any other duties as assigned by management
- Manage clinical data and work with Electronic Data Capture (EDC) systems, with strong attention to detail
- Build strong professional relationships with site staff and healthcare professionals.
Experience/Background
- Relevant education and clinical research experience to ensure that the job holder can effectively and confidently perform the duties of the role
Education and experience should indicate the candidate's capacity to:
- Interact confidently with study stakeholders
- Independently raise and discuss difficult issues
- Understand diabetes and its treatment, understand technical aspects of the ADC product line and business drivers
- Deliver studies according to Good Clinical Practice (GCP)
- Prioritise work assignments in an environment of complex and often conflicting inputs
- Analyse and digest product and clinical information
- Communicate well both verbally and in writing. Experience of working with medical devices and European and US regulations/standards affecting clinical investigations, in vitro diagnostic devices, medical devices and biologics (e.g. GCP, ISO15197, ISO14155) is desirable
Randstad Business Support is acting as an Employment Business in relation to this vacancy.
...
