Clinical Research Fellow Respiratory Medicine

Job overview

The job is fixed term for 12 months with further scope of extension. The post holder will support and manage high quality clinical research in Respiratory Medicine, according to ICH good clinical practice guidelines. The post holder will work closely with Dr Dexter Wiseman and Clinical Investigators at Chelsea & Westminster Hospital and Professor Jadwiga Wedzicha’s group at the National Heart & Lung Institute (50:50 split). At Chelsea & Westminster Hospital, the Clinical Research Fellow (CRF) will be involved in the development of protocol, guidelines and the post holder will ensure that governance arrangements are maintained throughout duration of studies; and studies are managed in accordance with study protocols, national and international legislation and guidance (e.g. Research Governance Framework, Clinical Trial Regulations, GCP); assessing patient suitability for studies, screening, obtaining informed consent; and recruiting patients in line with agreed targets, data collection and maintaining research study records.

Main duties of the job

• Research Responsibilities a) To contribute to study protocol design in collaboration with Clinical Research Lead and Pharmaceutical Companies and Academic Institutions representatives. This will include the writing of patient information leaflets, design of case report forms (CRFs) and source documents in line with the R&D standard operation procedures (SOPs). b) To ensure appropriate consent for research is obtained from the relevant patients c) To write concept sheets and full protocols or amend such documents which relate to the primary research carried out in respiratory medicine. d) Contribute to the promotion of Chelsea and Westminster Hospital Research and Development and the National Heart & Lung Institute and creating further funding opportunities. e) To represent the unit at meetings both locally and as required, at national and international locations; this includes Investigator meetings and Study Initiation meetings as well as attendance at Research Ethics Committee meetings. f) To undertake clinical responsibilities and research activities in Phase I-IV Research in Medicine.

Detailed job description and main responsibilities

• Research Responsibilities a) To contribute to study protocol design in collaboration with Clinical Research Lead and Pharmaceutical Companies and Academic Institutions representatives. This will include the writing of patient information leaflets, design of case report forms (CRFs) and source documents in line with the R&D standard operation procedures (SOPs). b) To ensure appropriate consent for research is obtained from the relevant patients c) To write concept sheets and full protocols or amend such documents which relate to the primary research carried out in respiratory medicine. d) Contribute to the promotion of Chelsea and Westminster Hospital Research and Development and the National Heart & Lung Institute and creating further funding opportunities. e) To represent the unit at meetings both locally and as required, at national and international locations; this includes Investigator meetings and Study Initiation meetings as well as attendance at Research Ethics Committee meetings. f) To undertake clinical responsibilities and research activities in Phase I-IV Research in Medicine. g) To provide clinical and professional supervision at Chelsea and Westminster Hospital NHS Foundation Trust, in collaboration with the Assistant Director of Research and Development to doctors and other staff (e.g. research nurses, research assistants etc.). h) To ensure that the dignity, right, safety, and wellbeing of all trail participants and give priority at all times i) To be available to work flexible hours as may be required by the design of particular clinical trial or the department’s needs. j) To participate in the analysis and publication of research results.
• Clinical Responsibilities a) To assess patients/volunteers eligibility for research protocols. b) To actively recruit and provide clinical care for patients/ volunteers enrolled in clinical trials. These duties will include obtaining informed consent, the management of medical problems and abnormal results on trials, reporting of adverse events and Serious Adverse Events, and the recognition and reporting of trial protocol deviation in the line of SOP. c) To prepare clinical trial prescription in a regular and timely manner in advance of scheduled patient/volunteer attendance, allowing pharmacy staff sufficient time for the preparation of study medication products. d) Be medically qualified and maintain GMC registration. e) Develop and maintain the competencies required to carry out the duties required of the post. f) Adhere to the Trust Customer Service Commitment and adopt a professional approach to customer care at all times.

Applicant requirements

You must have appropriate UK professional registration.

The postholder will have access to vulnerable people in the course of their normal duties and as such this post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 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.