Clinical Research Practitioner

Job overview

We're looking for a full time Band 5 Clinical Research Practitioner to coordinate and deliver clinical research studies at The Christie NHS Foundation Trust. The successful candidate will either be a registered Clinical Research Practitioner with the Academy of Healthcare Sciences or working towards registration.

We are looking for a highly motivated and enthusiastic individual who can contribute to the development of clinical research for people with cancer within the Gynaecology Research Team.

We have an extensive portfolio of trials, NIHR academic and commercial clinical trials. The role of the CRP will involve recruiting patients to these clinical trials, obtaining informed consent where appropriate, supporting patients enrolled in clinical trials, and ensuring study interventions are completed according to Good Clinical Practice (GCP) and Trust standards.

You will be working within a supportive team of experienced clinical research nurses and the clinical trial administration team.

Main duties of the job

The post will involve coordinating a portfolio of research studies across different specialties within the Trust and is ideal for individuals with an interest in Gynaecology and experience of working in a busy clinical / research environment who wish to further develop their skills and experience.

We are seeking candidates with experience in working in clinical research in the NHS that can demonstrate knowledge of Good Clinical Practice and clinical skills, such as phlebotomy. Strong communication and organisational skills are essential, and a flexible working approach is a key element to this role.

Detailed job description and main responsibilities

DUTIES AND RESPONSIBILITIES The specific responsibilities will depend on the requirements of each team, but may include: Management

• Provide induction support and training to new and existing clinical trials staff, including development of training sessions and guidance documents.
• Encourage the sharing of best practice and dissemination of information through regular structured meetings with all trials administration staff.
• Assist with metric tracking for performance indicators including mandatory training requirements, divisional key performance indicators (i.e. time to recruiting first patient from NHS permission, patient recruitment to time and target), amendment timelines and divisional absences. Clinical Research Co-ordination/ Data Management
• Interview, recruit, take informed consent and support patients and carers in non treatment clinical trials/studies. This involves educating patients on the trials involved, explaining the advantages and disadvantages of taking part in non treatment trials, whilst remaining unbiased at all times. Assess patients as required by trial protocols.
• Maintain adequate patient records and ensure all relevant information is documented in the patient’s medical and nursing notes.
• Provide continuity of care for patients and their carers throughout the trial programme. Provide non-clinical advice and support as appropriate. Ensure the provision of optimal patient care by alerting appropriate clinical colleagues when referral to other members of the MDT may be required.
• Act as a key point of contact with the R&D core team, study sponsors, clinical research organisations and specific research teams.
• Co-ordinate feasibility activities for new studies under direction from Clinical research Nurse Team Leaders and Principal Investigators
• Manage the set up and initiation of allocated clinical trials within assigned Clinical
• research Teams.
• Understand and deliver protocols in accordance with regulatory requirements
• Financial management of study set-up costs and income recovery for assigned clinical trials in conjunction with the R&D Business Planning and Finance teams with oversight from the Clinical Research Nurse Team Leaders/ Senior Clinical Research Nurses.
• Oversee maintenance of investigator site files and essential documentation in accordance with ICH-GCP and Trust Standard Operating Procedures (SOPs) to ensure they are kept inspection ready at all times.
• Assist with preparation for audit and inspections within assigned teams and implementation of action plans.
• Understand the process for obtaining NHS permissions (R&D approval) for conducting clinical trials at site. As project lead, ensure permissions are in place prior to any patient recruitment.
• Ensure all clinical trial activities are recorded in appropriate systems in a timely manner.
• Awareness of trial specific, regional and national targets. Identify and implement strategies for recruiting patients to clinical trials ensuring that targets for patient recruitment are delivered.
• Arrange and facilitate clinical trial related meetings.
• Undertake general administrative tasks as delegated by managerial representatives from the R&D division to contribute to the smooth running of the patient recruitment teams.
• Implement and coordinate reporting mechanisms to ensure that research staff complete and return proformas containing up-dated information on patients included in the study.
• Oversee and complete case report forms and participate in monitoring visits as per sponsor requirements.
• Ensure that data is available and up to date for any meetings related to the trial/ study, producing minutes as required.
• Attend project related meetings, investigator meetings (abroad or teleconferences, as necessary) to convey the relevant information to the study team.
• Attend disease-specific research team meetings to maintain an overview of team activity.
• Ensure that all documents are archived in the appropriate way by following the Trust’s archiving guidelines.

Clinical Service Responsibilities

• Demonstrate awareness of divisional and trust strategic objectives including performance indicators and metrics.
• Escalation of governance issues impacting on delivery of job purpose.
• To act as a primary contact point for the clinical trial patients for define clinical trials and act as adviser to other health care professionals.
• Participate in monitoring and audit activities within research team

PERSONAL AND PEOPLE DEVELOPMENT

• Maintain professional development whilst evaluating own specialist knowledge with assistance from their assigned line manager to satisfy the NHS Knowledge and Skills Framework.
• Participate in and deliver Trust-wide education programmes and study days, regional and national meetings and research seminars as appropriate.

PHYSICAL, MENTAL AND EMOTIONAL EFFORT

• Long periods of time spent using keyboard to input information and use of VDU for electronic communication.
• Prolonged concentration is regularly required (e.g. when checking through trial documentation and entering data into spreadsheets).
• Occasional exposure to distressed circumstances as trial patients are commonly suffering from terminal illnesses.

KEY VALUES • Demonstrates the agreed set of values and accountable for own attitude and behaviour.

Applicant requirements

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.