Research Practitioner Exeter

Job summary

We are seeking an enthusiastic and motivated researcher to join our busy research delivery team to ensure the smooth running of our portfolio trial, the ACORN II clinical trial.

The post is based in Manchester and the postholder will be required to visit scanning clinics in Manchester during their employment. You will be expected to work from home the majority of the time and will be provided with the equipment to do so. The post holder will be expected to liaise with the site lead Professor Anja Wittowski at the University of Manchester on a regular basis regarding the progress of the trial.

This is a Band 5 position. A total of WTE 0.6(22.5 hours) are available for 6 months.

Main duties of the job

The post holder will lead the safe conduct of research in antenatal anxiety as part of a NIHR HTA clinical trial. This may involve conducting research in secondary care and primary care. Research will be conducted in accordance with the Research Governance Framework, and for clinical trials in accordance with the International Conference on Harmonisation Good Clinical Practice (ICH GCP) guidelines and regulatory requirements to provide assurance that the rights, safety and well being of trial participants are protected. The post holder will use relevant knowledge to perform all research procedures according to protocols and extend this experience to support others in the research team and other health care professionals where appropriate. They will be accountable for the assessment, planning, organisation and ongoing care of research participants, whilst maximising compliance.

You will be required to attend trial study meetings, provide updates on recruitment and attrition for your site.

About us

We provide mental health, learning disability and neurodiversity services, as well as a range of specialist & secure services for the wider south west region & nationally. We are passionate about promoting good mental health & wellbeing. We strive to use the expertise & resources within our organisation, and through our partnerships, to deliver high quality services that are safe & focused on people's recovery.

We are committed to developing a culture of coproduction, involving patients, families & carers in everything we do

Duties and Responsibilities

• To communicate in a skilled and sensitive manner with patients, people who use services and their carers who may have specific difficulties in understand and/or communicating and who may be distressed.


• To work closely with colleagues in other multi-professional teams on a day to day basis.


• To communicate with a wide range of health & social care staff in hospital and in community settings in a skilled and sensitive manner, complex and sensitive information concerning the participation of the patient in a clinical trial.


• To maintain and build good working relationships with senior professional staff and managers in the Trust.


• Work with the multidisciplinary research and clinical teams to establish and maintain effective, collaborative relationships and networks with colleagues in the interest of participants and staff.


• Communicate effectively with all stakeholders, internal and external, involved in the research project.


• Provide reports, both written and verbal, to trial participants and clinical / research teams regarding the progress of the research


• To receive regular supervision in accordance with DPT policy guidelines


• To maintain and build on skills and competencies through annual appraisal and Personal Development Plans and attend training that takes account of evidence based practice and contributes to the team objectives. To undertake continuous professional development


• To work in accordance with all policies and procedures, including the support of equal opportunities and social inclusion.


• Take part in local, internal/external audits/inspection.


• To plan and prioritise own workload.


• To provide relevant knowledge to the planning, development and delivery of research projects.


• Liaise with members of multi-disciplinary research delivery team to establish procedures for the safe and smooth running of clinical trials.


• Attend team meetings, and appropriate clinics, to screen and recruit new patients.


• Perform appropriate assessments and rating scales as required for screening purposes and by the study protocol (training will be provided if required).


• Update appropriate patient databases to aid recruitment and reporting of recruitment.


• Evaluate patient eligibility for entry to clinical studies by coordinating pre-study tests, obtaining results and arranging appropriate appointments according to the study protocol. Ensure that subsequent study specific investigations are undertaken as required by the protocol.


• Facilitate the informed consent process ensuring that the patient fully understand the nature of the study; and ensure that the consent form is completed accurately and filed as required.


• The post holder will be responsible (where appropriate) for the assessments and documentation for follow up visits as per the trial protocols and in agreement with more senior research practitioners.


• Provide ongoing information, advice and support to patients regarding clinical trials.


• Maintain adequate patient records and ensure all relevant information is documented in the patients medical and nursing notes. Accurately document data collected into the case report forms


• Complete the electronic case report e-CRF and paper case report form, in a timely and efficient manner ensuring an audit trail is evident.


• Obtain any missing data and resolve queries with the clinical investigators and trial management office.


• In association with the local clinical team, ensure that all adverse events are recorded and appropriately reported.


• Maintain patient confidentiality at all times.


• Maintain an awareness of current advances in treatment, research and nursing practice and uses this knowledge to maintain the highest standard of care for patients with dementia and / or mental health conditions.


• Recognise that promoting the welfare and safeguarding children, young people and adults is everyone's business and access training and supervision as appropriate to the role.


• Raise concerns appropriately in line with the Trusts Safeguarding Adults Policy and the Child Protection Policy and interagency safeguarding procedures.


• Comply with recruitment and other checks as requested by the organisation including undertaking an Enhanced Disclosure via the Criminal Records Bureau.


• Take responsibility for the health & safety of themselves and other persons who may be affected by their omissions or actions at work


• The post holder is responsible for their own professional actions, acting within Trust policies and procedures and Professional Practice Guidelines, working within clearly defined occupational procedures.


• To follow policy guidance in own role and to comment on proposed policy changes and service developments.


• Careful use of equipment


• Responsibility for Human Resources, e.g. Supervision, Training, HR Advice and Management


• To maintain accurate records


• To be responsible for using an email account to generate, monitor, and respond to the e-mail traffic by which the Trust conducts much of its internal communication.

Responsibility for Research and Development

• Ensure a competent knowledge and understanding of the Department of Health Research Governance Framework for Health and Social Care, ICH GCP Guidelines and the Medicines for Human Use (Clinical Trials) amended regulations 2006.


• Assess and evaluate the progress of on-going clinical studies and provide regular updates to the Senior CSO/CRN, clinical trial coordinating centre, local line manager and other appropriate staff.


• Ensure clear and accurate record keeping.


• Attend scanning clinics at St Marys Hospital in Manchester to recruit participants into the trial


• Attend local and national meetings in relation to clinical trials as appropriate.


• Proactively promote clinical trials across participating NHS Trusts and develop and foster links with various stakeholders in order to facilitate the recruitment of participants, including identifying eligible patients


• Support study delivery by undertaking research activities outlined in approved study documents; facilitate the informed consent process as per legislation and the Mental Capacity Act, develop and maintain skills, experience and competence in administering rating scales, and conduct assessments with study participants


• Provide staff and participants with information about the studies, the rationale for their selection and the consequences of participating


• Develop sound relationships with participants based upon respect and an understanding of mental capacity and consent to participate in research


• Ensure that participants have good support mechanisms before, during and following their participation in the research study


• Demonstrate an understanding of the factors that affect recruitment to a research study


• Build effective working relationships with clinical teams and university staff


• Collect and maintain data and study documentation (including site files) in a systematic manner


• Ensure accurate data entry, and that all data collected is stored and used in compliance with relevant statutory instruments, national and local guidelines and regulations


• Undertake research activities using sound research ethics principles and adhere to Good Clinical Practice (ICH-GCP), Research Governance Framework, national and local practices and policies


• Support the management team in the event of inspection from a regulatory and/or monitoring authority


• Engage in multi-disciplinary meetings and reviews where appropriate


• Meet with Line Manager for supervision to ensure the research project is developed according to the project plan and conducted in a legal and ethical manner.


• Some duties may be necessary after normal working hours therefore some flexibility required in work schedule.


• Other tasks on an ad hoc basis relating to the research as required


• Work is managed rather than supervised


• Accountable for own actions manager is available for reference


• Manages own workload


• Prioritise work in an effective manner


• Work effectively with limited supervision


• Act independently and use own initiative to maintain collaborative research relationships with NHS, CRN and University staff


• Any Other Specific Tasks Required

Person Specification

Qualifications and Training

Essential

• Degree in psychology or relevant field, or relevant experience and associated clinical qualification in the area

Desirable

• Good Clinical Practice (GCP) training

Communication and Working Relationship Skills

Essential

• Excellent communication and interpersonal skills


• Evidence of accuracy and attention to detail in data collection.


• Ability to deal with the public and colleagues in a pleasant and polite manner at all times.


• Willingness and ability to travel to St Marys Hospital in Manchester

Desirable

• Understanding of the needs and sensitivity needed for pregnant individuals

Experience

Essential

• Experience of working with patients with perinatal mental health and/or mental health conditions


• Experience of administering psychological assessments/measurements


• Previous experience of working with a multidisciplinary team

Desirable

• Previous clinical research experience

Knowledge and Skills

Essential

• Clinical placements and/or supervised practice in a health care setting


• Knowledge of perinatal mental health and / or mental health conditions


• Familiarity with the issues surrounding clinical data, particularly confidentiality.


• Access to transport with the ability to travel if required


• An Enhanced CRB Check will be required for this role.


• Ability to work independently within defined occupational procedures and use initiative


• Ability to work as a member of a clinical team.


• Ability to tolerate ambiguity, and maintain own morale and motivation in challenging service delivery and research contexts.

Planning & Organisational Skills

Essential

• Ability to work autonomously using own initiative, and as a member of a team


• Self motivated with the ability to prioritise, organize and plan own workload


• Diplomatic and calm under pressure.


• Able to prioritise workload


• Excellent computer skills able to use all Microsoft office package


• Proficient in use of email, the internet and word processing

Analytical & Judgemental Skills

Essential

• Knowledge of GCP guidelines

Desirable

• Knowledge of research governance framework and current legislation


• Previous use of databases.


• Ability to integrate complex data; make evaluations formulations and decisions

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.