Clinical Research Practitioner

at  Nottingham University Hospitals NHS Trusts

ClinicalAssist research nurses/ACPs/Clinicians in delivery of patient care to research participants.Support and co-ordinate obtaining and processing of blood and tissue samples in the clinicalsetting as well as optimising recruitment via clinics and MDTs.Work alongside research nurses ensuring samples are collected and recorded per protocol.Review and record treatments, adverse events and response to treatment to relevant studydocumentation including source data and case report forms including electronic data entry.. Plan, prepare and participate in monitoring visits and respond to trial data queries.CommunicationTo function as a member of the Research and Innovation Clinical Trials Team to providededicated clinical trials support to research teams across NUH. Working within a multidisciplinary team, to co-ordinate a caseload of patients participating in local, national andinternational clinical trials in various treatment types.. Disseminate information to consultants regarding new trials on the National Institute ofHealth Research trial portfolio as well as non-adopted clinical trials, to enable optimal patientrecruitment.Ensure ethics and R&D approval and indemnities are in place before recruitment of firstpatients to a newly set up trial.
Facilitate the set-up of trials on site i.e. SSI submission viaIRAS account, liaise with trial centre and other relevant staff to organise trial set-up visits.Liaise with clinical teams to organise and ensure that trial specific investigations areundertaken as and when required, obtain the results, ensure eligibility and randomise thepatient.Liaise with medical staff to record organise and ensure the timely administration of treatmentand any necessary follow up investigations and visits.Liaise with histopathology ensuring tissue samples are stored via Tissue Bank guidelines,organising storage and catalogue of samples kept.To ensure effective communication with support departments to request and obtain specifictrial related information. E.g. Radiology copy scans, histological status and tissue samples.Organise the collection, storage and shipment of protocol specific samples.
Explain,dispense and collect patient quality of life questionnaires and diaries. Liaise with designatedPharmacist to co-ordinate the availability and dispensing of trial drugs if required.. Provide information to allow for invoices to be raised for payments where appropriate.Contribute to and supply verbal and written information on the teams portfolio of trials andthe number of patients recruited to the R&I team, hospital/university staff, local/Networkmeetings, regulatory bodies etc., as required.ManagerialMaintain patients records and accurately document data collected in case report forms andmedical notes, ensuring correct storage and maintaining confidentiality.Actively and independently participate in trial set up including gaining relevant permissionsand submitting SSI forms.To record trial activity on data systems and plan yearly Audits on recruitment as required bythe clinicians.. Forward trial data in a timely manner to the trial co-ordinating centre and liaise with theirpersonnel as necessary.Attend local and national meetings and feedback to members of the team..
Professional. Work alongside medical and nursing staff to assist in the informed consent process by givinginformation to patients concerning trials and allowing them to reach a fully informed decisionabout participation.To have specific and specialist knowledge of the patient pathway with regard to individualpatients diagnosis and the treatment options that are available to them.In discussion with the team leader, report adverse and serious adverse events to therelevant trial centre and site personnel, within the agreed timelines to ensure trial proceduresand patient safety parameters are met.Act as a contact point for the patient and their relatives. Maintaining contact with andproviding ongoing information and support to the patient in a sensitive and professionalmanner. Refer to other specialists as required in order to provide optimal patient care..
Participate in Continued professional development and undertake additional training asrequired per Knowledge Skills Framework and research staff competence framework.Speciality SpecificAssist in the review of trial protocols and identify resource implications for the site.Identify patients suitable for entry into clinical trials by attending clinics and Multi DisciplinaryTeam meetings.Ensure trial protocols are adhered to and that all personnel involved in trials are aware of anychanges or protocol amendments. Liaise with trial centres and relevant departments in orderto promote a good working environment and ensure the smooth running of clinical trials forpatients.Work at all times according to regulations described in NUH Policies, procedures andStandard Operating Procedures, Good Clinical Research Practice and European Directiveand R&I Standard Operation Procedures.NOTE: The duties and responsibilities of the post will be undertaken in accordance with the policies,procedures and practices of the Nottingham University Hospitals NHS Trust, which theHospital will amend from time to time. Copies are available on each Ward and Department. Itis the individuals responsibility to keep up-to-date with these and other policy document

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