Job Description
The post holder will play a key role as a member of the Research Team providing clinical study support to various clinical specialities conducting research in the trust and other public health and social care environments.
To support research projects contributing to a comprehensive, efficient, and effective administration service within research.
The Clinical Trials Assistant will be responsible for the collection, recording and maintaining data for patients on NIHR portfolio studies.
The post holder will support research staff in ensuring the completeness, accuracy and consistency of the data in order to meet standards expected for reporting to regulatory bodies.
This role will involve working closely with Clinical Investigators, Research Nurses and other members of research teams to maintain holistic support for all clinical trial participants, thus facilitating a high-quality research service.
The post holder will be expected to interact with trial participants in relation to the requirements of the clinical trials and be able to work without supervision in some areas.
The post holder is responsible for assisting the Clinical Research team, R&I Unit staff, laboratory personnel on the feasibility and impact of pathology support for research studies conducted or proposed at HDFT. In addition, s/he will assist, supervise and organise the management of research sample processing and storage within Pathology.
Patient support
To assist in the evaluation of patient eligibility, in liaison with other appropriate health care professionals for clinical trial entry, involving the co-ordination of pre-study tests, taking bloods, obtaining results/X-Rays and arranging appropriate appointments as per clinical trial protocols.
To assist the co-ordination of the patient’s journey through the clinical trial protocol e.g. requisition and organisation of any necessary investigations, procurement of patient notes and X-Rays, support of patients attending outpatient clinics.
Obtain clinical specimens from patients, store and package as required or organising appropriate storage, processing and delivery in path lab.
Ensure source data and other appropriate documentation is filed securely in patient notes
Team Working
To disseminate information appropriately about the current trials portfolio.
To provide feedback to members of research teams on issues relating to recruitment, protocol amendments and trial results.
To disseminate information from the National Institute for Health Research or similar bodies to local research teams.
The post holder will demonstrate the ability to manage their own administrative case-load, working as part of the multidisciplinary team.
In conjunction with all members of the team and appropriate healthcare professionals, develop a cohesive and flexible team working environment across the Service.
Harrogate and District NHS Foundation Trust (HDFT) provides a wide range of services to the population of Harrogate and its surrounding district. The resident population served is approximately 200,000 and the hospital has approximately 300 beds.
HDFT as a partner organisation in the Yorkshire and Humber Clinical Research Network is committed to supporting research activity as part of the service it provides. In addition as an NHS organisation it aims to ensure that as many patients and staff as possible have the opportunity to take part in research. To deliver research activity HDFT has an established Research department which sits in the Corporate Services directorate. The Research department receives funding from the NIHR via the regional clinical research network host for the delivery of research activity.
The Research & Innovation (R&I) Department is led by the Associate Medical Director (AMD) for Research and Innovation and is managed by the R&I Manager/Research Matron, supported by the Senior Governance Officer and Senior Research Nurse. Delivery of research is supported by the departments of Finance, Pharmacy, Pathology and Radiology.
To work as a key member of the Research & Innovation Team, duties include:
Provide administrative support for research activity across the trust to assist the co-ordination and facilitation of concurrent research studies.
Ensure compliance within the network, NHS trusts and partner policies on data protection, confidentiality and security.
In addition to clinic/patient-based tasks, this role includes document generation and control, project tracking and logistics, data collection, adherence to good clinical practice and research governance and assisting in the continued improvement in the care of research participants and quality of research data.
The post holder will also be responsible for developing and sustaining their own knowledge, clinical skills and professional awareness.
The post holder is expected to adhere to Trust policies and procedures and relevant legislation including the requirements of any professional bodies and to attend mandatory training as identified by the Trust.
Particular attention is drawn to the following requirements:
INFORMATION GOVERNANCE AND DATA PROTECTION
All employees are required to:
- Protect information about the Trust, its staff and its patients in accordance with the Trust’s Information Governance Policies and Data Protection Laws during and after the termination of employment.
- Only access information that they are required to do so as part of their role.
- Implement the appropriate technical and physical measures to ensure that information is safe and secure.
- Familiarise themselves with the Trust’s Information Governance policies and Data Protection Laws.
- Undertake Data Security training on an annual basis.
Failure to comply with or adhere to the Trust’s Information Governance Policies or data protection legislation will be treated as misconduct under the Trust’s Disciplinary Policy, which may result in dismissal or criminal proceedings. The Trust’s Information Governance Policies are available on the Trust’s intranet page.
As an individual, you do have the right to apply to view or have copies of your own records via the appropriate routes. You do not have the right to directly access your own records. Inappropriate access to information will be treated as misconduct under the Trust’s Disciplinary Policy which may result in dismissal and/or criminal proceedings.’
INFECTION CONTROL
In order to comply with the Health Act 2006 (Code of Practice for the Prevention and Control of Health Care Associated Infections) it is the responsibility of every member of staff to prevent and control the spread of infection following the Trust’s infection control policies. These are available on the intranet in the Infection and Prevention Control section. If, as a routine part of your job, you do not have access to the intranet please discuss with your line manager how you can access this information to ensure that you are familiar with your responsibilities.
SAFEGUARDING
HDFT takes its responsibility to safeguard and protect the welfare of both adults and children very seriously. During the annual appraisal process appraisers will use the appropriate documents to work with post holders to identify the relevant competencies necessary for this role and ensure the post holder is competent to undertake any appropriate duties or requirements to safeguard adults and children.
For child safeguarding issues the relevant documents are the HDFT Child Protection Training Strategy and the Intercollegiate Document “Safeguarding Children: the Roles and Competencies of Health Professionals.” For adult safeguarding issues the relevant documents are the HDFT Safeguarding Adults policy, particularly the Training Needs Analysis.
Safeguarding also means ensuring that fundamental aspects of care, such as appropriate nutrition, preventing falls and minimising the risk of pressure ulcer formation, is provided for each patient in our care.
HEALTH AND SAFETY
All Managershave a general accountability for ensuring, so far as is reasonably practicable, the health, safety and welfare of the employees under their direction at work.
All employeesare required to:
- take reasonable care for their own acts or omissions and the effect that these may have upon the safety of themselves or any other person.
- use safety equipment or clothing in a proper manner and for the purpose intended.
- note that any employee who intentionally or recklessly misuses anything supplied in the interests of health and safety will be subject to disciplinary procedures.
- work in accordance with any health and safety procedures, instructions or training that has been given.
- not undertake any task for which they have not been authorised and for which they are not adequately trained.
- bring to the attention of a responsible person any perceived shortcoming in our safety arrangements or any defects in work equipment.
- note that all employees are under a duty to familiarise themselves with the Risk Management, Fire, and Health & Safety Policies.
- undertake mandatory training in accordance with legal requirements (fire and governance training is required annually and health and safety training is a single event).
CORPORATE GOVERNANCE ARRANGEMENTS
You will be expected to familiarise yourself with the Trust’s Governance Strategy which outlines the Management and Committee Structures and Procedures for the Governance of the Trust’s activities.
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