Specialty Doctor - Clinical Research

Job overview

The speciality doctor – clinical research supports clinical research activity across the Trust’s RD&I portfolio and is integral to the operation of Halton Clinical Research Unit (HCRU). The role leads on or supports all aspects of trial set up, delivery and management, with key responsibilities in patient safety and trial conduct.

Main duties of the job

The postholder will:

• Act as principal or sub-investigator and provide medical cover as part of a multidisciplinary team for commercial and non-commercial clinical research studies, delivering those studies safely, on time and to target, complying with the regulatory requirements.
• Engage as appropriate with all aspects of the development and conduct of research studies, including the submission and maintenance of regulatory documents, the recruitment and follow up of subjects and providing medical cover. The postholder will work to ensure that all studies are conducted to Good Clinical Practice.
• Maintain accurate records (paper and electronic) as required by regulatory authorities, Sponsors and local policies.
• Engage in all aspect of the overall business of the R&D department ensuring delivery of the Trust’s vision for research.
• Engage with local Research Delivery Network (RDN) to ensure Trust is meeting targets for RDN priority areas.

Detailed job description and main responsibilities

• Support a range of clinical research studies within their clinical expertise being conducted at the Trust.
• Build excellent relationships and work with individuals and departments across the Trust/partner organisations/staff groups, in particular the Research Nurse, Midwife and AHP teams, to aid the smooth set-up and running of clinical research studies.
• Assist with the identification of studies potentially suitable for the Trust, including supporting applications to Sponsors on behalf of the Trust.
• Help with the set-up of clinical research studies, as lead or as a member of the research team, in a Principle Investigator role as appropriate.
• Be responsible for specific study-related medical decisions within their expertise, and, where appropriate, in consultation with the study Principal Investigator/s for the studies conducted within the Trust.
• Provide and arrange medical cover for studies in the Trust. In partnership with the principal investigators and staff, initiate definitive strategies to anticipate and expertly manage medical safety issues, including emergencies.
• Act as medical member of staff responsible for participant queries in normal working hours and out of hours, contributing to the medical research on call rota
• Interact and collaborate with study team personnel responsible for creating study protocols and related documents, including local Research Ethics Committee (REC) documentation and R&D submissions.
• Assist with monitoring visits.
• Arrange localised training for research studies conducted at the Trust, including attendance at study-specific training.
• Assist with the writing and review of appropriate Standard Operating Procedures in association with relevant departments.
• Take a leading role in advertising and recruiting to clinical trials.
• Where appropriate take responsibility for overseeing the management of administration of study drugs for designated studies to healthy volunteers/patients according to local standard operating procedures.
• Assist in the training and development of medical and nursing staff, including planning and provision of seminars and lectures.
• Maintain accurate and accessible research records and provide formal reports where required.
• Assist PIs in assessing and reporting adverse events in accordance with the protocol and regulatory requirements.
• Participate in research meetings and internal seminars.
• Take part in or conduct any other duties as may be deemed reasonable by the PI/R&D Director.
• Ensure and maintain compliance with intellectual property rights and the Data Protection Act 2000.
• Ensure and maintain compliance with COSHH Health and Safety Guidelines within the Laboratory.
• Ensure and maintain compliance with relevant Trust policies, including Financial Regulations, Equal Opportunities Policy, Promoting Race Equality Policy, Health and Safety Policy, Information Systems Security Policy and Intellectual Property Rights and Register of Interests Policies
• Ensure all competencies and training is up to date for relevant studies and all work complies with Good Clinical Practice
• It is the responsibility of the post holder to ensure they are registered for continuing professional development and are responsible for keeping themselves abreast of new developments and best evidence based practice.
• The post holder will be supported to maintain clinical experience in a related speciality within a suitable department within the trust. Timing of this activity will be balanced against the workload within the clinical research unit and will account for no less than 10% of DCC on average.
• The post holder will be considered for study leave to attend formal courses, conferences, etc., and the funding will be available according to the agreed terms and conditions of service for the medical staff within the NHS
• The post’s job plan will be reviewed annually in keeping with the Medical Staff Job Planning Policy.

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.