RESEARCH & DEVELOPMENT JOB DESCRIPTION JOB TITLE: BAND: DEPARTMENT MANAGERIALLY ACCOUNTABLE TO: PROFESSIONALLY ACCOUNTABLE TO:

1. JOB SUMMARY 6 Research & Development / Trust wide Senior Research Associate Professional Service Lead / Assistant Director of Nursing Head of Research & Development Junior Research Associate (Generic)

This is a 2-year fixed term post during which the post holder will assist the Senior Research Associate with the set up, maintenance, and close down of clinical studies, in accordance with local, national and international legislation. The post will entail assessing patients suitability, ensuring informed consent is obtained; co-ordinating the logistics for patient visits and undertaking patient assessments in accordance with study protocol. All data will be recorded, including adverse and serious adverse events, in accordance with ICH-GCP. Facilitate the set-up of studies working with the R&D Support Office and relevant networks. It will be the postholders responsibility to ensure studies are delivered in line with agreed targets. The post holder will be line managed by the Senor Research Associate, but supported through the R and D department and the Assistant Director of Nursing, as appropriate. There will be opportunity to maintain a clinical contribution through negotiation with the R and D dept if wanted. 2. KEY RELATIONSHIPS:

The post holder will work closely and collaboratively with lead investigators, senior research staff, study sponsors, research networks, professional R&D leads, clinical support staff (e.g. pharmacy, radiology and pathology), other nurse teams, and the Research & Development Support Office to deliver research and maintain a high standard and profile of clinical research. 3. KEY RESPONSIBILITIES 3.1 Clinical Trial Set Up Contribute to the assessment of trial protocols and safety, regulatory and logistical issues in the running of the trial Contribute to trial feasibility meetings Facilitate Site Specific Assessment procedures Liaise with the R&D Support Office to ensure all projects have been given full R&D and REC approval prior to commencement Liaise with NIHR Clinical Research Network personnel in the trial set-up Support senior staff to undertake trial set up 3.2 Clinical Trial Management

Obtain informed consent from participants for non-CTIMP studies (i.e. observational and questionnaire) as instructed by principal investigator and within parameters of the protocol. Support participants considering taking part in research with the decision-making process, ensuring that their information needs are met sensitively and that they have a full understanding of the research study and its requirements. Support local Principal Investigators in meeting their responsibilities outlined in the Research Governance Framework, Medicines for Human Use (Clinical Trials) Regulations Maintain Investigator Site File(s) and complete Case Report File / eCRF with a high degree of accuracy Support PIs to ensure all Adverse Events are reported in line with the Trust Adverse Events Reporting policy Support the PI in ensuring all reporting to regulatory bodies and Research Networks (if applicable) is done in a timely manner Facilitate and maintain (written and verbal) communication between the PI, research and clinical teams in ensuring that the study protocol is correctly implementation and research governance standards are met and maintained. Support the study team to ensure that all equipment used in the trial is appropriately calibrated and ensure retention of supporting documentation. Perform all visits, observations, and interventions with the participants in accordance with the procedures and schedule of the study protocol and as directed by the senior research staff and under supervision of Senior Research Associate. Be responsible for ensuring the submission and communication of monthly recruitment / accrual figures direct to the NIHR or appointed Accrual/Recruitment Data Contact, R&D department and other stakeholders under the guidance of senior research staff Ensure protocol amendments are incorporated into research practice Undertake suitable studies under guidance and supervision of the Senior Research Associate / Allied Health Professional (AHP) o Provide and receive complex information in the process of explaining study involvement and obtaining informed consent for the identified studies. o Under the supervision of Senior Research Associate / AHP undertake the management of the research related care of a group of study participants over the period of the identified study, which includes: o The assessment of patients/volunteers for eligibility for research and monitoring their condition throughout their participation. o Assist in recruitment, follow up and data entry during the period of the trial. o Acts in the best interests of the research subjects to ensure their rights are upheld. Work within the range of research guidelines, ethical principles and protocols, whilst adhering to organisational policies and procedures. Contribute to Clinical Governance at a level appropriate to the post holders knowledge and experience. Observe the confidentiality of patient information at all times, in accordance with the Data Protection Act and Caldicott regulations. Develop research related knowledge in relation to research governance, International Conference of Harmonisation Good Clinical Practice and the EU clinical trials directive Communicate with Senior Research Associate / research nurse teams / R&D / NIHR Clinical Research Network lead regarding research subjects, trial progress, workload issues and personal development. Develop research knowledge and advanced clinical skills including assessment techniques appropriate to post holders knowledge and level of responsibility 3.3 Study Close off Ensure all data clarification issues are resolved quickly Manage the archiving of study related documentation in line with the Trial Agreement and ICH-GCP

3.4

Resource Management Be responsible for the handling of patient valuables and the reimbursement of patient expenses incurred as a result of study participation. Shared responsibility for the safe use, maintenance and storage of computers, photocopiers and other office equipment. Contribute to effective stock control/maintenance. Contributes to selection and purchase of study specific equipment and clinical supplies

3.5

Education / Strategic / Other Maintain high quality working practices and ensure standards are met with assistance from senior staff (e.g. Senior Research Associate, PI) Identify own learning needs and proactively seek clinical educational opportunities through the clinical area, R&D and NIHR Clinical Research Network as appropriate. Will be expected to facilitate the knowledge and development of other staff by ensuring that clinical and research staff is made fully aware of local research opportunities, active studies, requirements for recruitment, protocol requirements, responsibilities of clinical and research staff, and governance requirements. Develop skills in accordance with RCN Competency Framework for Research Nurses appropriate to the Band 6 role Undertake and maintain ICH-GCP Training Maintain own professional registration, if appropriate, through effective use of CPD opportunities Competent in and use on a daily basis of word, spreadsheet and database programs and patient administration systems Regularly use software to develop documents or reports, including spreadsheets for external agencies where manipulation of the formulae is required (e.g. electronic data capture). Promote the Trusts Organisational Objectives Promote research within the clinical environment

Other Requirements/ Responsibilities Quality Improvement / Clinical Governance Assist or participate in departmental and Trust initiatives or audits, related to Quality Improvement / Clinical Governance. Training and Development The post holder will be required to actively participate in a periodic performance appraisal, in accordance with the Trust guidelines. The post holder is encouraged by the department to attend both personal and professional development activities that assist in their role and the service. The Trust has a statutory duty to involve service users, carers and the public in the work of the organisation. We consider that Patient and public involvement is the responsibility of every individual working for our Trust. All staff has a responsibility to listen to the views of patient and to contribute to service improvements based on patient feedback. You will be expected to support the Trust in this aim through your working practice.

PERSON SPECIFCATION Department: Research & Development Post Title: Junior Research Associate Band: 6 1. FACTORS Physical Requirements ESSENTIAL Health Clearance from Occupational Health for the role specified. DESIRABLE

2.

Education/Qualification e.g. education, qualifications, Registration requirements.

First Level Registered Nurse, with current live Registration or Allied Health Professional (AHP) An individual with significant experience working in a clinical research environment

Degree in health-related subject or equivalent MSc postgraduate degree level or equivalent

OR

3.

Previous Experience e.g. paid and unpaid relevant to the post.

Experience of working in clinical settings.

4.

Skills, Knowledge, Abilities

5. Aptitudes, Personal, Characteristics e.g. aptitude for figures, special demands of the post.

Knowledge of research process (e.g. design and methodology used in clinical research) Good IT skills with use of Microsoft (Word, Excel and PowerPoint) Excellent communication skills, verbal & written (including report writing and record keeping) Excellent interpersonal skills with patients, carers, clinical staff and multidisciplinary team Able to work within a diverse community of patients and health Effective personal time and case load management Self motivated Able to use own Initiative Approachable manner Ability to work under pressure Team player Excellent organisational skills Good time management

Experience of coordinating delivery of clinical trials (i.e. set-up, delivery and closing studies) Experience of a range of clinical skills , e.g. venepuncture, IV drug administration etc Knowledge and/or training in Good Clinical Practice Awareness of informed consent process in research Knowledge and understanding of research governance (regulatory and legal framework)