About this role
Job summary
The post holder will be responsible for oversight and leading of Early phase and Oncology clinical research trials within the Clinical Research Facility . This will involve the use of a novel and advanced drugs and devices. You will work as part of and be supported by a multi-disciplinary research team with a strong track record of producing high quality research outcomes.
The post will be based at Guys Hospital, in the phase 1 MHRA accredited Clinical Research Facility. However, it is a requirement that you be prepared to work at any additional or different location owned or served by the Trust, either on an on-going or temporary basis according to the demands of the service.
Main duties of the job
You will coordinate and lead research projects as a sub-investigator, recruit and follow up patients according to trial protocols, collect and analyse clinical data, maintain trial documentation, and contribute to publications and presentations. The role also includes participation in specialist clinics and close collaboration with principal investigators and wider research teams. You will be responsible for over seeing the delivery of clinical trial IMP and for the safety of participants recruited to trials.
About us
The Phase 1 MHRA clinical research facility is one only two NHS based Clinical research facilities accredited in England. The team deliver both phase 1 and advanced investigational therapies across the various specialties with a high proportion of trials sitting within the Oncology and Haematology clinical areas. The Research facility is part of a wider Clinical research facility, with an adult unit at St Thomas providing space and support for phase 2 studies, a cardiorespiratory unit at the Royal brompton, an Imaging unit also at St Thomas and a paediatric unit at the Evelina.
Job description Job responsibilities
As the CRF and Oncology Fellow the post holder will:
Support the timely delivery of clinical studies to acceptable medical standards, in-line with the requirements of sponsors, ICH GCP, and other appropriate guidelines and regulations. Provide medical assessment and cover for selected early phase studies in the CRF working alongside the CRFs senior clinical team, the OHCT early phase research team and the nurse in charge; In partnership with the CRF Physician and clinical staff, initiate definitive strategies to anticipate and expertly manage medical safety issues, including emergencies; Support aspects of subject recruitment, including pre-study medical histories, informed consent, medical examinations for ongoing studies, dosing of study medication; On a rota basis, provide medical cover outside of normal working hours, as determined by the nature of the studies being undertaken in the CRF at the time; This can include twilight and night shift cover. Accept delegated responsibility to ensure that assigned studies in the CRF are carried out safely and in compliance with the protocol; Be responsible for specific study-related medical decisions as agreed with the Study Principal Investigator; Perform clinical procedures as appropriate to the assigned study (including, but not limited to, clinical examinations or testing, insertion of intravenous lines, assessment of adverse events and management of medical emergencies); Ensure that patients/volunteers in assigned studies give fully informed consent in writing before commencing a study; Assess the eligibility status of referrals for experimental treatments, maintain and update a screening list. Evaluate and manage acute, sub-acute and chronic adverse drug reactions and manage acute toxicological emergencies under the supervision of the consultants or CRF physician in charge. Assess and interpret safety and clinical data from assigned studies, e.g. Vital signs, ECG's, laboratory tests, adverse events etc; Follow up and report adverse events as necessary. Communicate safety issues to the Principal Investigator for a study, the Head of Department or Designee, report Serious Adverse Events to the study sponsor in accordance with Good Clinical Practice; Review study documentation and complete appropriate sections of Case Report Forms; Ensure that all clinical activities within the CRF are conducted in accordance with approved Standard Operating Procedures (SOPs) Maintain accurate and accessible research records and medical notes; Provide medical input into integrated clinical, safety and statistical reports as requested; Contribute to the risk assessment and planning of risk mitigation strategies for early phase trials; Ensure personal Trust mandatory training is up to date and support the training of medical, nursing and ancillary staff as required; Any other duties as may be deemed reasonable by the CRF or the Oncology Early Phase leadership; Participation is expected in clinical, research delivery activities, governance and other service activities with the object of ensuring a high standard of patient care, including some overnight weekday resident responsibilities on a rotational basis.
Person Specification
Qualifications and training Essential
Full GMC Registration and hold a licence to practise in the UK
Desirable
Post CMT MRCP or equivalent
Clinical experience Essential
Broad based general professional training in general medicine Research experience
Desirable
Experience with Oncology
Knowledge and skills Essential
Ability to work as an effective member of a multidisciplinary team Capable of establishing good interpersonal relationships with patients and staff of all grades
Desirable
Understanding of clinical risk management Competent to work without direct supervision where appropriate
Research Essential
Understanding of the principles and applications of clinical research
Desirable
Evidence of original research Publications in peer-reviewed journals Experience of working on complex advanced therapies trials
Management Essential
Evidence of understanding of the role of clinical management
Desirable
Evidence of leadership in the development of clinical services
Other Essential
Evidence of understanding of and adherence to the principles of Good Medical Practice set out by the General Medical Council Evidence of contribution to effective clinical audit and clinical risk management Excellent computer literacy (email, Microsoft Word, Excel, databases).
Desirable
Experience in clinical guideline development
Disclosure and Barring Service Check 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 (formerly known as CRB) to check for any previous criminal convictions.
Certificate of Sponsorship Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).
From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).
UK Registration
Applicants must have current UK professional registration. For further information please see NHS Careers website (opens in a new window).
Employer details Employer name Guy's and St Thomas' NHS Foundation Trust
Address Guys Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom
Employer's website https://www.guysandstthomas.nhs.uk/careers/careers.aspx (Opens in a new tab)