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• To work autonomously to manage research studies, maintaining effective communication with patients, carers and other healthcare professionals to ensure high quality service delivery.
• To ensure that research study specific investigations are undertaken as required by the trial protocol in order to establish eligibility and safety to enter the trial.
• To act as a resource and support to patients and carers, explaining practical aspects of research studies and working with clinical teams to map patient pathways as required.
• To arrange collection of samples required as part of the research study and ensure safe and appropriate storage of specimens in conjunction with local support services staff.
• To maintain comprehensive patient records and ensure all relevant information is documented and uploaded in the patient’s healthcare records.
• To be responsible for accurate and timely completion of case report forms (CRFs).
• To monitor participants for toxicity/side effects and ensure that changes to treatment are effected as required by the research study protocol.
• Record and report any adverse events that occur whilst the patient is in the research study to the relevant personnel and through the Trust reporting system, acting as required.
• Report and record all serious adverse events, within the prescribed time period, that occur whilst the patient is in the research study to the local Principal Investigator, research study personnel as required and through the Trust reporting system.

MANAGEMENT AND ADMINISTRATION

• To ensure that research study recruitment records are accurately maintained and data contemporaneously recorded in healthcare records.
• To maintain study site files and documentation.
• To liaise with Trust support services as required by the research protocol to ensure safe and smooth running of the study.
• To access appropriate computer systems in order to retrieve relevant information.
• To ensure that research studies are effectively archived as required in compliance with GCP principles, trust policies and study requirements.
• To provide information as required for the raising of invoices related to research studies.
• To provide support for research colleagues and attend meetings relevant to the post.

EDUCATION AND TRAINING

• To act as a resource for colleagues in relation to research studies.
• To assist in the education of all relevant health care professionals to enable them to care for research study patients.
• To keep all appropriate staff informed of the progress of research studies.
• To keep up-to-date on research related topics in general and as appropriate to caseload and interest.
• To assist in the preparation of posters for meetings and conferences both locally and at other events as required.
• To assist with the education and training portfolio of the R&D Department delivering training sessions on research and research related topics as required.

RESEARCH AND AUDIT

• To contribute to the management of the local portfolio of research studies and assist in the identification of research studies for introduction to research teams.
• To maintain and expand understanding of research governance and the implication to research.
• To identify patients eligible to enter research studies, registering and randomising patients into clinical trials as required completing pre-study tests where necessary.
• To facilitate the informed consent process ensuring the following is accounted for:

Ø  The patient (and significant others) fully understand the nature of the research study.

Ø  The patient is aware that entry into the trial is voluntary and they can withdraw at any point without prejudice.

Ø  The patient is aware of any extra procedures required by the trial.

Ø  The consent form is completed accurately and filed as required.

·         To be responsible for the accurate collection and inputting of research study data in a timely manner including screening of potential patients for clinical trials and evaluating eligibility.

·         To assist the clinical service and wider research team with the production of a research participant recruitment and retention strategy for each assigned research study.

• To be flexible and adaptable to help other research departments as required and as own trial burden permits.

·         To accurately record data on trial pro-forma, co-ordinate monitoring visits from sponsoring companies and respond promptly to data queries.

PROFESSIONAL RESPONSIBILITIES

• Work within the NMC Code of Conduct.
• Be responsible for developing and sustaining own knowledge, clinical skills and professional awareness in accordance with re-validation requirements.
• Conduct the research in accordance with the relevant guidelines i.e. GCP Guidelines, the study protocol, the UK policy framework for health and social care research and any other trial manuals in order to protect the research participants and the quality of each study.
• To safeguard the interests of patients by liaison with relevant trial personnel and contribution to trial design and protocol and ensure compliance with research guidelines.
• To observe the confidentiality of participant information at all times, in accordance with the Data Protection Act 2018 and GDPR.