Job Description

The Research Assistant Practitioner will provide clinical and administrative support to clinical research teams, ensuring the safe conduct of research in accordance with the regulatory and legal frameworks relating to the planning, undertaking and closure of research studies, providing assurance that the rights, safety and well-being of trial participants are protected.



The post holder will be supported through a comprehensive training/competency package as appropriate to the job role and will assist in the identification, recruitment and management of participants into a portfolio of research studies including but not restricted to commercial and non-commercial clinical trials. Having completed all relevant competencies and under the supervision of registered nursing staff they will also be responsible for the co-ordination and management of a portfolio of research studies that do not involve administration of medicines and contribute to the delivery of clinical trials within bounds of their clinical practice.



Please note that sponsorship is not eligible for this post.

Closing Date:

Please be advised that this job advert will close as soon as sufficient applications have been received. Please apply for this job as soon as you can, if interested.



Successful applicants will be required to provide an immunisation and vaccination report, from either their current UK occupational health provider or their UK GP.



The job holder may be required to carry out other similar or related duties which do not fall within the work outlined in the description which may reasonably be required to deliver a comprehensive research service to our patients. The Line Manager, in consultation with the post holder will undertake any review.



Provide appropriate information to patients and their carers participating in studies.



Arrange patient assessments and visits as appropriate to relevant study protocol



Assist the research team in the preparation and conduct of the clinic visits for patients enrolled in research study



Under supervision or after appropriate training, carry out clinical procedures including but not limited to vital sign measurement, ECG acquisition, phlebotomy and cannulation, height, weight blood pressure measurements



Report all findings from clinical procedures to research team and accurately document as advised by team in appropriate research files, logs and databases and patient records



After appropriate training and assessment of competence process blood, urine and other samples according to protocols such as preparing serum separation using centrifuge and pipetting. Preparing for ambient or frozen storage and shipment as directed



Arrange couriers for safe and timely transport of all clinical samples



Attend multi-disciplinary meetings to support the team with patient identification and recruitment



University Hospitals Coventry and Warwickshire NHS Trust, rated as good by the Care Quality Commission, is one of the largest teaching Trusts in the UK.



We are extremely proud of our employees across our hospital sites, with high quality patient care at the heart of everything we do.



Boasting some of the most modern facilities in Western Europe, the Trust is renowned for being at the forefront of research and innovation as part of its blossoming reputation as a worldwide leader in healthcare.



We are proud to be recognised as a Pathway to Excellence designated organisation - please click the link for further details about this prestigious award. Pathway To Excellence - University Hospitals Coventry & Warwickshire (uhcw.nhs.uk)



By joining our exciting journey, you will form part of a passionate, talented team and will be able to access a wide range of learning and development opportunities. There has never been a better time to join our team.



The Trust is committed to building an organisation that makes full use of the talents, skills, experience, and different perspectives available in our diverse society. We want everyone to feel they are respected, valued, can achieve their potential and receive the most appropriate and relevant care. We will create an environment where the equality and human rights principles of fairness, respect, equality, dignity and autonomy are promoted and are part of the organisation's core values.

Research Teams:

This summary contains the core responsibilities as listed, allowing for a core job description to be used across Specialties enabling standardisation of the responsibilities.



The post holder will be employed by the Research and Development Department (R&D) to work to work flexibly across several research speciality teams as service requirements dictate.



They will contribute to the provision of a clinical research service based normally at the location of the employing organisation (UHCW NHS Trust); however, travel to other sites may be required as per study requirements or set out under contractual agreements for the delivery of a local cross cutting clinical research service.



Research



Support Research Nurses and Physicians by assisting in the planning and conduct of all types of research studies



Adhere to trial protocols and work in accordance with ICH GCP and Trust Standard Operating Procedures.



Manage and co-ordinate own portfolio of uncomplicated studies, not requiring qualified medical/ nursing intervention in accordance with the relevant Local, National and International guidelines



Use databases to access patient groups to improve patient opportunity and recruitment to trials



Identify/screen patients for studies and registers/ enrol patients into these studies, ensuring informed consent is in place



After appropriate training and competence assessment obtain written informed consent for allocated non-interventional research studies as delegated by the Principal Investigator



Co-ordinate and manage a portfolio of non-interventional research studies in line with protocol ethics approvals



Coordinate the follow up of an identified caseload of trial patients with minimal supervision



Day to day maintenance of patient records whilst the trial is in progress, data entry onto electronic or paper based case records forms



Assist in the preparation of and participate in monitoring visits, and respond to data queries



Ensure serious adverse events are reported and acted upon as required by the protocol in liaison with a research nurse and or Principal Investigator



Facilitate the secure filing and storage of study documentation and maintain specific site files in accordance with ICH-GCP and research Governance



Ensure clear, concise and accurate records are kept for research projects in accordance with all regulatory requirements including the data protection ac



Ensure that all ICH GCP required documentation is kept in a clearly traceable system and is stored in an appropriate manner for the appropriate length of time



Where required, data is transcribed accurately into the Trial Master File and maintain in accordance with ICH GCP



Maintain accurate records of study recruitment as per local procedure and status of studies providing regular updates. This will involve ensuring that EDGE (local patient management system) is updated with key trial data and feeding back through the local portfolio team meetings



When appropriate enter patients onto hospital alert systems



Utilise information and IT systems to secure accurate and timely patient data.



Be proficient in IT applications to produce standard letters and other communications as appropriate



Attend start up meeting as required and assist with the start-up of clinical trials



Communicate with research departments both within and external to the Network



Assist with archiving study material upon trial closure



As directed assist research participants in completing trials related assessments such as paper or electronic questionnaires



Support the research participants through the process of trial participation



Communicate effectively with members of the MDT to keep them updated on trial progress



Assist in the maintenance of study site files



Refer to other team members when risks and needs are beyond own scope of competence and scope of practice.



Education, Training and Development



Keep up to date with departmental Trust, NHS and EU developments for the implementation of clinical research

Undertake any training and assessment of competency required for the role

Attend courses, meetings and conferences as deemed relevant and appropriate

Responsible for developing and sustaining own knowledge, clinical skills and professional awareness

Keep up to date with GCP training, in line with study/sponsor requirements and Trust Operating Procedures.



Other



Update and maintain mandatory and statutory training as required by the Trust

Be flexible in approach with working times and workload management

Assist the research Nurses in orientation of new staff to the department.

Observes confidentiality of patient information at all times in accordance with the Data Protection Ac



For further details of the role please see the attached job description.