Clinical Research Associate Oxford, England
Job description
The research administrator and clinical assistant role is vital to support the research team and ensure smooth communication, coordination and administration in the delivery of research. The post-holder will work with the Trauma research trials team to help deliver all aspects of Trauma clinical studies within the Oxford University Hospitals NHS Foundation Trust (OUHFT). This will be in accordance with ICH-Good Clinical Practice (GCP), clinical trial regulations, standard operating procedures (SOP’s) and Trust policies. The post-holder will be responsible for daily activities relating to studies within their level of competence.
To understand that all research must be conducted according to ICH-GCP, the Directive on Good Clinical Practice and the Research Governance Guidelines and assist the team in upholding these standards.
To follow agreed protocols and policies, seeking advice where appropriate from the research team and the lead trial teams.
To work with research nurses in the provision of a high standard of practice and develop working relationships with other multidisciplinary teams and areas of the Trust involved in clinical research activity.
To demonstrate a professional approach to work and act as a professional and responsible team member.
To have the capacity to work independently, on your own initiative and set own work priorities.
To provide help and information in a polite, positive and concise manner.
To assist with the day to day smooth running of the Trauma research office.
To develop and maintain effective communications to foster good working relationships with all key stakeholders, internal and external contacts. To deal sensitively and appropriately with all communications within the team, the trust, other trusts and external sponsors.
Trust Standards• The post holder is responsible for ensuring that all duties and responsibilities of this post are carried out in compliance with the Health & Safety at Work Act 1974, Statutory Regulations and Trust Policies and Procedures.
- All staff, both clinical and non-clinical, are required to adhere to the Trusts’ Infection Prevention and Control Policies and make every effort to maintain high standards of infection control at all times thereby reducing the burden of Healthcare Associated Infections including MRSA.
- The post holder will endeavour at all times to uphold the rights of children and young people in accordance with the UN Convention Rights of the Child.
- The Trust is committed to safeguarding children and vulnerable adults throughout the organisation. As a member of the trust there is a duty to assist in protecting patients and their families from any form of harm when they are vulnerable.
- All staff must complete annual information governance training. If you have a Trust email account this can be completed on-line, otherwise you must attend a classroom session.
- Data quality is a vital element of every member of staff’s job role. Oxford University Hospitals recognises the importance of information in the provision of patient care and in reporting on its performance.
To ensure all eligible trial patients are registered in a timely manner and have the correct forms completed that the trial requires.
To ensure accurate and timely completion of both case report forms (CRF) (paper and electronic) through identification and extraction of source data via the patients notes and help to maintain study databases such as REDCAP and OPENCLINICA.
To help maintain and update the Trauma research intranet and internet websites.
To recognise your own strengths and limitations and ask for help when unsure and thereby act as a responsible practitioner.
To oversee the organisation and maintenance of the Kadoorie Research computer drive.
To be responsible for maintaining and updating all essential documents in the Investigator Site Files.
To ensure up to date case report forms (CRF’s) are available at the site at all times for all studies.
To ensure that current up to date trial protocols are available in the centre at all times and updated on the appropriate systems as required.
To act as first telephone contact for enquiries about trials/research and be confident to provide non-clinical advice to patients/clients/relatives/staff.
To support the team in preparing documentation for monitoring visits including ordering of medical records, arranging suitable meeting rooms and act as a liaison when monitors are on-site.
To support the administration of clinical trials through involvement with regular team meetings and take good quality minutes.
To work closely with the research staff to resolve data queries and with the planning, running and closedown of studies.
To prepare for and help with audits by the Trust Research Department and/or Regulatory Authorities for GCP compliance.
To help with study closure and archival preparation.
To attend relevant local, regional and national meetings related to specific trials as required.
Clinical
To assist with clinical observations as required by study protocols under the supervision of qualified staff. Training will be provided.
To ensure clinic appointments/tests required for patients involved in studies are carried out according to the agreed schedule.
To assist in the care and follow up of study patients. Where appropriate and for specific studies, the post holder may be expected to obtain patient informed consent to participate in a study, provide information, education and support to patients on clinical trials.
To be aware of and notify the research team of identified Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs).
To process, package and ship samples according to specific protocols and in accordance with GCP principles, training will be provided.
Personal/Professional Development
To develop knowledge of clinical research in the relevant discipline.
To develop knowledge of ethical issues in relation to research.
To undertake training in aspects of clinical studies and clinical trial administration, including ICH GCP & data collection.
To undertake mandatory and other training as required and enter onto /relevant training database.
Comply with the all Policies and Procedures of Oxford University Hospitals Foundation Trust and those issued by local NHS Trusts.
To recognise and use spontaneous and formal learning opportunities and share knowledge and experience with other staff.
To learn and employ skills as the role develops and expands under the supervision of qualified staff.
About Oxford University Hospitals NHS Foundation Trust
CEO: Dr Bruno Holthof
Revenue: $100 to $500 million (USD)
Size: 10000+ Employees
Type: Hospital
Website: www.ouh.nhs.uk
Year Founded: 1980
