Detailed job description and main responsibilities

1. FEASIBILITY AND STUDY SET UP

- Contribute to the set-up of research studies within the wider research team. Liaise with the R&I Professional Services Team, Principal Investigators and support departments to ensure a thorough feasibility process

- Able to identify and plan strategies for recruiting patients into studies. Working with Principal Investigators to develop initiatives to increase patient involvement

2. SUPPORT

- Assist in the selection and recruitment of participants in compliance with study inclusion / exclusion criteria

- Receive informed consent and provide ongoing information, education and support to clinical study participants (and their carers)

- Assist in achieving NIHR High Level Objectives and GHNHSFT Key Performance Indicators for patient recruitment, speed and quality of research

- Liaise with multi-disciplinary team members to teach and demonstrate procedures for the safe and smooth running of clinical studies and act as a training resource to other members of the clinical team and a contact point in matters concerning study participants and study protocols

- Act as a role model for delivery team members

- Act as a supervisor for students as applicable to professional registration

3.STUDY DELIVERY/MONITORING

- Good knowledge of clinical research studies, including, but not limited to: Research Governance Framework and Good Clinical Practice for Clinical Studies

- Ensure the safety and wellbeing of clinical study participants, including safe administration of treatments and drugs that are given within the context of a clinical study, as applicable to professional registration and Trust POPAM policy

- Reporting of serious adverse events to all relevant personnel, following the relevant Standard Operating Procedures

- Assess patients as required by study protocols and take appropriate and timely action for participants with treatment toxicities, where appropriate

- Perform study specific clinical observations and assessments as mandated by study protocol: Venipuncture, test urine samples and administer treatments for which training has been given, as applicable to professional registration, R&I Standard Operating Procedures and Trust POPAM policy

- To be responsible for requesting internal monitoring reports for locally sponsored/hosted studies and actioning as required

- Responsible for actioning externally sponsored monitoring reports in a timely manner

- Ensure study protocols are followed and that studies are conducted according to the Research Governance Framework Procedures, R&I Standard Operating Procedures and Good Clinical Practice

- Maintain a safe environment for patients, staff and visitors

- Comply with Trust policies and guidelines

- Ensure study records are accurately maintained, including, but not limited to: records in nursing/medical electronic and paper notes, case report forms and study site files

- Adhere to requirements to protect confidentiality

- Maintain study records on EDGE (Clinical Studies IT system)

4.OTHER DUTIES

- Support the embedding of clinical research within our Trust

- Contribute to strategies that inform Trust staff of current clinical studies activity/progress

- Respond to change in line with the needs of service provision, working flexibly within the delivery team

- Identify own learning needs and proactively seek educational and training opportunities to develop and maintain competency

5. COMMUNICATIONS AND WORKING RELATIONSHIPS

The post holder will be expected to communicate with a variety of stakeholders at all levels including but not limited to:

- National Clinical Trials Units

- Pharmaceutical companies

- Other research Sponsor organisations

- Clinical Research Network staff

- Researchers

- Support service staff and clinicians both within Gloucestershire Hospitals NHS Foundation Trust and beyond

6.MOST CHALLENGING PART OF THE ROLE

- Working across several studies with varying deadlines

- Liaising and working with investigators, support departments and clinical trials units

- Encouraging other professionals, outside of the Research & Innovation team, to take an interest in and support clinical studies

- Implementing and promoting Good Clinical Practice for research

- Frequent interruptions to concentration from staff members, telephone, etc

- Mental effort – long periods of concentration required on often lengthy documents

7. General Working Conditions

- Physical effort is not strenuous, occasional lifting of boxes of A4 paper, A4 files and similar (up to 5kg), and transporting these to other departments

- Work is primarily performed in the Ophthalmology Research Unit in GRH however on occasions you may be required to work in CGH

- At least 60% of the time will be spent working in an office, with regular use of the computer

- At least 40% of the time will be spent working in clinical areas (research unit and Ophthalmology clinics) talking to participants, taking blood, testing urine samples, ECGs, vital signs and administering some treatments as applicable

- The post involves a combination of sitting, standing and walking