Assistant Research Practitioner

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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.