Additionally, the post holder will be expected to provide clinical supervision and care for patients in trials, manage adverse events, and actively contribute to the publication of research findings. The ideal candidate should possess strong communication skills, maintain GMC registration, and demonstrate a commitment to patient welfare. Flexible working hours may be required depending on trial designs, and involvement in the Trust's commitment to customer service and professional development is crucial.
The post holder will lead on development and maintenance of high quality clinical research environment. Will initiate and manage clinical activities related to academics studies and clinical trials and will carry case load of patients from multiple studies, from initiative to termination, according to ICH good clinical practice guidelines. To work within research guidelines, ethical principles and protocols, whilst adhering to organisational policies and procedures.
Chelsea & Westminster Hospital NHS Foundation Trust is a research active organisation. We are looking for enthusiastic Clinical Research Physician to support studies in the Clinical Research Facilities (CRF). The post holder will support and manage high quality clinical research at the Clinical Research Facilities, according to ICH good clinical practice guidelines. The post holder will work closely with the Clinical Research Facilities Lead and Clinical Investigators. The Clinical Research Physician 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 post holder is 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 post holder is expected work across the Trust, attend local and national meetings, present in conferences, write up and publish their work in medical indexed journals.
About us
1. Key Responsibilities
Research Responsibilities
a) To generate research ideas that could become concept sheets in liaison with the trial sponsors (Pharmaceutical Industry, Academic Institutions, MRC or Trust) funding approvals and development into grant applications.
b) 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 CRF standard operation procedures (SOPs).
c) To write concept sheets and full protocols or amend such documents which relate to the primary research carried out by Clinical Research Facility (CRF).
d) Contribute to the promotion of Chelsea and Westminster Hospital Research and Development 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 all specialities.
g) To provide clinical and professional supervision in collaboration with Assistant Director 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 departments needs.
j) To participate in the analysis and publication of results from research conducted by CRF and others and where appropriate to present such data in public forum.
k) To maintain up-to-date knowledge of all applicable CRF SOPs and follow these in daily research activities.
l) To prepare, review and update CRF SOPs as required according to the applicable schedules.
m) To assess of all SEA 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.
n) To keep well organised, legible and accurate records.
o) To meet with study monitors regularly to assist with clarification of data queries in order to maintain quality assurance
p) To participate in audits or inspection of CRF sponsored clinical trials as well as external sponsored studies as required.
q) To assist in both internal and external training requirements (general and study-specific) in liaison with Lead Nurse and other Clinicians.
r) 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.
Clinical Responsibilities
s) To assess patients/volunteers eligibility for research protocols.
t) To actively recruit and provide clinical care for patients/ volunteers enrolled in clinical trials conducted in CRF. 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.
u) 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.
v) Be medically qualified and maintain GMC registration.
w) Develop and maintain the competencies required to carry out the duties required of the post.
x) Ensure patients are involved in decisions about their care and to respond to their views.
y) Adhere to the Trust Customer Service Commitment and adopt a professional approach to customer care at all times.
z) Develop clinical practice through self-reflection and learning from experience, application of research into practice and active contribution within the multi-disciplinary team.
aa) Demonstrate, model and encourage trust values at all times to all patients and staff. Participate in audit and quality improvement
bb) Involve in clinical duties, providing clinical care to patients in outpatient Clinics as required by the service.
2. Financial Responsibilities
a) To actively contribute with the cost calculation of studies proposed for CRF.
b) Sensible management of unit resources.
3. General Responsibilities
a) Pay due regards to your own safety and the safety of others.
b) Adhere to protocol laid down, SOP and ICH GCP Guidelines.
c) Seek and give advice as appropriate
d) Ensure that standard of quality and safety is maintained.
e) The post holder will be required to show evidence of participating in continuing professional development by attending regular local, national and where appropriate international meetings.
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