Clinical Research Fellow

Job overview

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.

Detailed job description and main 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 CRF’s 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.

Applicant requirements

You must have appropriate UK professional registration.

This post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service.