Job responsibilities
Clinical
To ensure high standards and continuity of care for research participants during the study and maintain lines of communication.
To contribute to the ongoing development of the research undertaken by the Practice.
To possess theoretical knowledge of the relevant disease process and to ensure that all theoretical and practical knowledge relation to disease process is developed and maintained.
To keep up to date with the changes in Primary Care in order to improve patient care.
To assess patients/volunteers for eligibility for research and to monitor their condition throughout their participation.
Research
To safeguard the interest of patients by liaising with relevant trial personnel and contributing towards trial design and protocol.
To undertake an active role in the ethical requirements, including research ethics submission, the informed consent process and participant support.
To be involved in the process of gaining ethics approval for research studies and guide members of the research team through the ethical approval process.
To provide ongoing support, advice and information to patients/volunteers with regard to their participation in clinical research in order to obtain effective informed consent, ensuring that it is an ongoing process.
To obtain continuing informed consent from the trial participant prior to carrying out procedures and treatments as agreed within the trial protocol.
To assess and evaluate the progress of on-going clinical trials and research undertaken in the Practice, maintaining an accurate account of the status of the projects and to regularly update the Partners.
To immediately report, using the appropriate procedures, Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs).
To ensure that all proposed research projects carried out in the Practice are registered and reviewed by the Partners prior to commencement, and that the updates and amendments are reported in a timely fashion.
To be able to critically read a research protocol, understand the methodology and its practical application within pragmatic local requirements for the trial.
To use expert knowledge to assess appropriateness of research design and methodology and possess an understanding of the analytical process.
To apply knowledge of the ethical principles for clinical research.
To possess and apply specialist knowledge of the roles of the National Research Ethics Service (NRES), Governance Arrangements for Research Ethics Committees (GAfREC), and Research Ethics Committees (RECs).
To provide advice and support to other members of the multidisciplinary team with an in-depth knowledge of ICH GCP and R&D and REC registration and approval in relation to project development, implementation, completion, and dissemination.
To ensure compliance with ICH GCP guidelines.
At all times to ensure clear, accurate records are created and maintained, developing data collection, case report forms and Quality Assurance (QA) systems for data collected by other members of the research team.
To ensure the implementation of standard operating procedures (SOPs) for research and to support programmes of training in SOP implementation.
To review and lead the development and implementation of Clinical Research undertaken within the Practice.
To offer support and guidance in ethical principles to members of the Research team.
Communication
To establish lines of communication to promote and oversee the appropriate referral and recruitment of patients to research within the Practice for which the postholder has a designated responsibility.
To establish and maintain good working relationships and effective communication channels with supporting clinical services, and within the ICS.
To establish and maintain good channels of communication with the ICS, non-commercial organisations, and sponsors.
Education
To be responsible for developing and sustaining own knowledge, clinical skills, and professional awareness.
To provide ongoing advice and information to patients/volunteers with regard to their condition or provide additional referral if necessary.
To drive and encourage the participation in original research carried out in the Practice for self and junior members of the team.
Where appropriate, prepare results of research and present as posters or scientific presentations at meetings and conferences.
Where necessary, critically analyse and disseminate findings, acting as an ambassador for the Practice by undertaking presentations and teachings.
To act as a resource to non-research staff with regard to educating on conduct of clinical research process within the NHS.
Management
To be responsible for the practical organisation and management of trial participants and the administration of information.
To be responsible for ensuring that essential trial documentation is kept in a clearly trackable system, is stored for the appropriate time, and meets ICH GCP requirements.
To monitor and plan in advance the workload of the Practice, ensuring it is adequately resourced.
To lead the preparation for and facilitate audit by the Partners and/or Regulatory Authorities for GCP compliance.
To take responsibility for the supervision and management of the Research Administrator.
To actively participate in the recruitment of Research Nurses/Study Site Co-ordinators when necessary, and to contribute towards the development of their job descriptions.
To act as a resource and role model for members of the team.
To work independently and autonomously without direct supervision.
To implement effectively changes in relation to departmental, NHS, Practice, and regulatory development for the management of clinical research.
To ensure that policies and procedures of the Practice are adhered to and to work within own scope of Practice.
To be responsible for the management of developing, reviewing and updating of SOPs. Also, to review other relevant Practice protocols to ensure they are applied appropriately.
SUPERVISION RECEIVED
The post holder will be operationally line managed by a Dr Lucy Pocock.
SUPERVISION EXERCISED
The post holder has day-to-day line management responsibility for the Administrator.
KEY WORKING RELATIONSHIPS
Develop and maintain key working relationships with:
Practice GPs, Practice Nurses, Pharmacists, Paramedic Practitioners and HCAs
Patients and Carers
Practice Management, Reception and other Administrative staff
Secondary Care and interface colleagues
Community Nurses and other allied health professionals
Community Pharmacists and support staff
Social prescribing link workers
Voluntary sector colleagues
CONFIDENTIALITY
Under the Data Protection Act 2018 (alongside the EU General Data Protection Regulations) the post holder must maintain the confidentiality of information about patients and staff. The work is of a confidential nature and information gained must not be communicated to other persons except in the recognised course of duty. Unauthorised disclosure of confidential information may result in disciplinary action and may lead to your dismissal.
EQUALITY & DIVERSITY
The post holder will support the equality, diversity and rights of patients, carers and colleagues, to include:
Acting in a way that recognises the importance of peoples rights, interpreting them in a way that is consistent with the networks, procedures and policies, and current legislation.
Respecting the privacy, dignity, needs and beliefs of patients, carers and colleagues.
Behaving in a manner which is welcoming to and of the individual, is non-judgemental and respects their circumstances, feelings, priorities and rights.
HEALTH & SAFETY
Employees must be aware of the responsibilities placed on them under the Health & Safety at Work Act (1974) to ensure that the agreed procedures are carried out to maintain a safe environment for patients, visitors and staff, including infection prevention and control.
SAFEGUARDING
To be fully aware of and understand the duties and responsibilities arising from the Childrens Act 2004 and Working Together in relation to child protection and safeguarding children and young people as this applies to the workers role within the organisation.
To also be fully aware of the principles of safeguarding as they apply to vulnerable adults in relation to the workers role, which will include recognising the types and signs of abuse and neglect and ensuring that the workers line manager is made aware and kept fully informed of any concerns which the worker may have in relation to safeguarding adults and/or children.
REHABILITATION OF OFFENDERS ACT
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for disclosure to be made to the Disclosure and Barring Service to check for any previous criminal convictions.
INFORMATION RESOURCES AND RESEARCH AND DEVELOPMENT
Be proficient in being able to access a range of information, from a variety of sources/systems, in order to be able to collate and analyse this information in order to inform the development of a variety of reports. E.g. tender bids, business cases, board reports etc.
Undertake regular research into areas such as national policy, the local and national market for services similar to those provided by the local Health Authority.
Investigate local/national/international best practice and compart this to current service delivery in order to understand organisational development needs and to advise senior members, including the board of the implications of this in making key strategy, service development and commercial decisions.
This information will need to be compiled into well-structured and considered reports with the methodology by which this has been completed outlined and able to stand up to scrutiny.
