Research Clinician
5 months ago
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 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
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