Clinical Research Facility Clinical Fellow

The Department of Research & Development (R&D) has an opportunity for a Clinical Research Fellow to work in the dedicated Clinical Research Facility (CRF) located at the Northwick Park Hospital Site in Harrow. The successful candidate will be a GMC registered Medical Practitioner, with relevant and substantial hospital service, including a desire to gain experience managing clinical research patients and healthy participants. Research training will be provided.

The post holder will be responsible for recruitment and consent of trial participants, management of adverse events, protocol review and development, clinical oversight, ensuring all trial conduct is in accordance with GCP and the applicable national regulatory clinical trial standards, and aspects of clinical trial and CRF administrative management. The post will be part of a multi-disciplinary team consisting of both nursing, allied health professionals, clinical research practitioners/coordinators and administrative support. The post holder will report to Dr Ashley Whittington, Clinical Lead for the CRF and Consultant in Infectious Diseases and General Medicine. The exact role will be tailored to the clinical experience and areas of interest of the successful candidate. This would be an ideal opportunity to publish independent research or strengthen a subsequent application to speciality training.

Main duties of the job:

• Outpatient care of research patients and participants being treated as part of trials performed in the CRF.
• Co-ordination and execution of trial activities for the CRF, including obtaining informed consent for patients, checking eligibility of research patients, randomization, study specific investigations, sample collection and handling, data collection, case record folder completion, maintenance of study documentation.
• The post holder will be expected to actively support and participate in both external and internal clinical research monitoring and audits including any regulatory inspections.
• The post will involve regular liaison with clinical trial sponsors, contract research organisations (CROs) and attendance at site selection and initiation visits.
• Under supervision, to undertake the setting up of clinical trials, including where required protocol design, grant applications, regulatory and ethical submissions, liaison with clinical trials units and preparation of study specific documentation.

The post holder's duties will be primarily located at Northwick Park Hospital but their presence may from time to time be required in other parts of the Trust.

NIHR and commercial studies:

The research fellow will be expected to continue participation of the LNWUH in NIHR portfolio studies and/or relevant commercial studies. This will involve recruiting patients to studies and developing strategies to ensure patient enrolment is meeting targets. The research fellow will work closely with the R&D department to ensure study delivery maintains research governance standards which is key to Trust research performance. The research fellow will also be involved in identifying new studies, examining the feasibility of participation of these studies, facilitating set up of new studies and then supervising their implementation until study completion. This role supports an ongoing sustainable research programme which funds the research in the department through ongoing research activity. Close working with R&D and the relevant staff supporting the Trusts research will be key to a successful outcome.

Clinical work:

You will not be expected to do routine clinical work but may be asked to help in exceptional circumstances. There is an opportunity to undertake weekly clinical sessions in a desired speciality if the candidate desires to broaden their clinical experience.

Person Specification:

Qualifications:

• MBBS (or equivalent)
• MRCP UK (or equivalent)
• GMC
• BSc
• MSc
• DTM&H

Knowledge:

• Completed Foundation Training
• Experience in Clinical trials and Research
• Experience in Management of acute medical emergencies
• Completed core medical training
• Experience in urgent public health & vaccine research
• Management and Audit
• Awareness of clinical governance
• Personal involvement in audit project(s)
• Principal investigator in research project
• Experience in feasibility and recruitment planning in clinical research
• Involvement and Understanding of the operational functions and management of clinical research facilities

Research / Publications:

• Keen interest in clinical research and appreciation of major research questions
• Experience and knowledge of clinical trial methodology including the conduct of early and late phase trials
• Awareness of Research Governance and GCP training
• Knowledge of IRAS and ethics/HRA approval

Language:

• Able to speak and write English to fulfil job requirements

Personal Skills:

• Effective team member with good communication skills
• Good organisational skills
• Self-starter who completes tasks set by themselves and supervisors
• Flexibility and adaptability

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.