Clinical Research Fellow Hepatology 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 Hepatology Medicine, according to ICH good clinical practice guidelines. The post holder will work closely with Dr Daniel Abeles and Clinical Investigators at Chelsea & Westminster Hospital

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. The CRF are also expected to ensure that all research safeguards the psychological and physical well-being of the patient in conjunction with medical and nursing staff to facilitate high standards of care with regards to research. The CRF is expected work across the Trust, attend local and national meetings, present in conferences, write up and publish their work in medical indexed journals.

Main duties of the job

• 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 Hepatology medicine. d)     Contribute to the promotion of Chelsea and Westminster Hospital Research and Development and 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.

Detailed job description and main responsibilities

• Key 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 Hepatology medicine. d)     Contribute to the promotion of Chelsea and Westminster Hospital Research and Development and 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. k)      To maintain up-to-date knowledge of all applicable R&D SOPs and follow these in daily research activities. l)        To assess of all Serious Adverse Events (SAE) to determine whether a suspected unexpected serious adverse reaction (SUSAR) has occurred and to ensure timely reporting in line with the current applicable regulatory requirements. m)  To keep well organised, legible and accurate records. n)     To meet with study monitors regularly to assist with clarification of data queries in order to maintain quality assurance
• )     To participate in audits or inspection of Trust sponsored clinical trials as well as external sponsored studies as required. p)     To assist in both internal and external training requirements (general and study-specific) in liaison with Lead Nurse and other Clinicians. q)     The post-holder will be required to build on existing close relations with colleagues as part of a multidisciplinary team. He/she will also be required to support quality improvement, research and management of the service. r)       To assist and help supervise post-graduate students and visiting workers s)      To undertake appropriate administration tasks t)       Contribute to departmental management as required u)     To undertake any necessary training and/or development v)      Any other duties commensurate with the grade of the post as directed by the Principal Investigators w)    The post holder will be expected to contribute to the intellectual activities of their host department and to keep up to date with scientific advances in the field
• 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. g)      Develop clinical practice through self-reflection and learning from experience, application of research into practice and active contribution within the multi-disciplinary team. h)     Demonstrate, model and encourage trust values at all times to all patients and staff. Participate in audit and quality improvement