Detailed job description and main responsibilities

Knowledge, Skills and Experience required

Leadership and Managerial

Manage own workload effectively and delegate roles appropriately

Constantly review study performance, identify opportunities for improvement and suggest new strategies

Encourage, motivate and support research colleagues, and enhance retention

Provide day-to-day supervision of other Research staff, including sickness management, appraisals, performance management etc.

Write SOPs (Standard Operating Procedures) and guidelines for practice for use by research staff, following national guidance from Health Research Authority (HRA), using specialist clinical knowledge.

Provide new ideas and initiatives, facilitate their implementation and evaluate outcomes

Participate in the management of change

Strive to continuously develop resources, facilities and services

Support research-active clinicians and encourage potential Principal Investigators

Support research personnel in other departments

Incorporate flexible approach to accommodate the unpredictability of the workload

Promote a healthy and safe working environment

Clinical

Demonstrate knowledge and skills commensurate with significant specialist clinical experience

Ability to learn, assimilate and retain new clinical knowledge as required for each research study

Understand complex clinical information across multiple specialities

Understand and be able to explain the concept and details regarding each study, where there may be barriers to understanding and where concepts may be complex.

Employ specialist knowledge to assess the suitability of patients for inclusion in a study

Demonstrate skill at interpreting complex clinical information and data

Ability to review medical notes and hospital databases to extract relevant information

Display insight into workload and demands of clinical colleagues, displaying empathy and flexibility

Competence in clinical skills required for research study visits including venepuncture and a variety of clinical measurements

Use hospital information systems and wider NHS systems effectively and appropriately to collate and analyse data.

Participate in clinical decision-making regarding patient treatment and care, where a range of options may need to be analysed in relation to ongoing participation and results.

Research

Take responsibility for all aspects of study conduct

Work autonomously to manage their caseload of studies and patients, whilst working as part of the research team

Actively seek potential research study opportunities and promote SWFT as an attractive site

Establish, manage and complete studies across multiple specialities in the Trust

Perform feasibility assessment for potential studies and submit Expression of Interest as appropriate

Facilitate study set up which includes liaising with clinical staff, ensuring equipment and supplies are available, documentation is prepared, approvals are in place, study training is completed, recruitment strategies are agreed, access to databases is organised.

Develop a working knowledge of both the theoretical and practical aspects of each research study

Identify barriers to recruitment and assist in finding solutions

Attend and contribute to Site Initiation Visits, Investigator meetings, Study team meetings

Undertake study activity alongside other members of the research team, leading on own studies and cohorts of participants, including screening potential study participants, checking eligibility, approaching patients, obtaining Informed consent, collecting and uploading data, performing study visits, delivering interventions, handling and processing samples, completing follow ups, attending to data queries, maintaining study documentation and files, liaising with study teams, organising study close-out and archiving

Ensure patients are randomised and allocated treatment in accordance with the clinical trial protocol

Perform study activity with regard to timelines and targets

Keep Principal Investigator updated

Demonstrate advanced computer skills and be able to use databases, spreadsheets, flowcharts and tables

Maintain study site information files, manage version control, archive documentation and ensure security of data, confidentiality and anonymity

Implement study amendments and communicate effectively with R&D governance team

Collect, manage and upload data accurately

Forward trial data in a timely manner to trial teams, including responses to data queries

Supply trial progress data/information as required to senior managers, Trust R&D departments and Management Systems

Maintain, troubleshoot and operate specialist study devices and laboratory equipment for the purpose of each study

Check stock levels of study supplies and ensure timely replacement as required

Perform laboratory procedures as required for each study, including centrifuging and aliquoting

Arrange and prepare transport of specimens including hazardous substances

Monitor, analyse and classify Adverse Events, Serious Adverse Events, SUSARs (Suspected, Unexpected, Serious Adverse Reactions) and report to regulatory authorities as required

Conduct all aspects of research in accordance with ICH (International Conference for Harmonisation) GCP (Good Clinical Practice) guidelines, relevant legislation, SOPs and protocols

Prepare and participate in clinical trial audit and monitoring conducted by sponsoring companies and regulatory authorities

Store, maintain, handle, dispense and dispose of study medication in strict accordance with ICH GCP, IMP (Investigational Medicinal Product) and manufacturer’s guidelines

Accurately enter pertinent information into patient’s medical notes

Act as patient advocate ensuring the best interests of the patient are upheld at all times

Provide expert clinical care, advice and support to study participants and their families

Be aware of and promote study involvement opportunities for patients

Disseminate study results to clinical teams

Promote patient and public engagement in research and seek feedback

Education, Training and Development

Mentor, support and train research delivery colleagues, imparting acquired knowledge and skills

Disseminate internal and external learning opportunities for research team members

Promote a learning environment within the research team

Educate the multidisciplinary team about each study and achieve ongoing effective communication ensuring dissemination of information and providing opportunity for them to contribute ideas and suggestions

Act as a resource of clinical and research expertise, both theoretically and practically

Utilise recently published research to promote evidence based practice

Facilitate research training for the wider team in the Trust, utilising expertise within the core team

Provide medical trainees with opportunities to engage with research, achieve authorship in publications and acquire acknowledgement of their research participation for CV enhancement

Promote and support the Associate PI scheme

Maintain professional registration and sustain own knowledge and skills

Keep up to date with developments and initiatives in the Trust, NHS and wider arenas

Attend relevant lectures, conferences and symposia and contribute as appropriate

Seek feedback and identify own development needs

Professional

Responsible for, and demonstrate commitment to, own personal and professional development, identifying needs and utilising all reasonable opportunities to maintain and advance personal and professional knowledge and skills

Assess own educational needs, arrange personal training and keep up to date with clinical advances and current issues

Set personal and professional standards and seek performance appraisal and feedback

Promote the professional Research Nurse role within the multidisciplinary team

Act as professional representative for the Trust at local and national level

Maintain a political awareness of issues pertaining to research

Contribute to the field of research knowledge

Practice in a confident and competent professional manner

Act as credible role model

Act and work autonomously, managing own workload, planning own time effectively and efficiently

Evaluate own performance and instigate plans for improvement

Provide cover for colleagues

Aware of implications of and have an understanding of current legislation pertaining to research

Conduct clinical research according to ICH GCP guidelines

Aware of and adhere to Good Laboratory Practice (GLP)

Work in accordance with UK Policy Framework for Health and Social Care Research

Practice at all times within the NMC Code of conduct, taking responsibility for own actions and seeking guidance from senior colleagues where appropriate

Recognise and work within HCPC Scope of Practice

Keep up to date with Trust mandatory training

Communication

Communicate effectively in a wide variety of situations with ability to deliver complex, specialist information at an appropriate level for the recipient

Liaise with clinical staff to explain requirements of study and the extent of their required participation

Maintain regular communication with clinical staff to ensure appropriate recruitment and study conduct

Liaise with Consultants and PIs (Principal Investigators) to ensure availability of patient cohort, understand patient pathways, complete required documentation, agree strategies for screening, recruitment and study visits

Communicate in a knowledgeable, professional manner with study teams, CTUs (Clinical Trial Units), Trial Managers, sponsors, couriers, diagnostic laboratories and other external agencies to ensure smooth study conduct

Liaise with other research staff, both locally and in other Trusts, and share information and resources

Awareness of other research studies that participants may be enrolled in and liaise with other research groups

Establish links with Primary Care, Community teams and other NHS Trusts

Build and maintain a network of effective contacts within the Trust and external organisation