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A healthcare organization in Exeter is looking for an individual to manage clinical trial coordination, ensuring patient confidentiality and accurate documentation. The role involves working closely with multidisciplinary teams and requires excellent communication skills. Ideal candidates will have a relevant healthcare qualification and experience in coordinating clinical research. This position requires someone who can manage their own workload effectively.
To communicate in a skilled and sensitive manner with patients, people who use services and their carers who may have specific difficulties in understanding 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, providing complex and sensitive information concerning the participation of the patient.
To provide support & guidance in the application of psychological principles and techniques, and to foster reflective practice.
To maintain and build good working relationships with senior professional staff and managers in the Trust.
To plan and prioritise own workload.
To provide relevant knowledge to the planning, development and delivery of research projects.
Liaise with the 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 (and carers/family) fully understand the nature of the study; and ensure that the consent form is completed accurately and filled 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 (and carers/families) 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 use this knowledge to maintain the highest standard of care for patients with dementia and/or mental health conditions.
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.
To assist the work of less experienced assistants and/or trainees as required.
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.
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 local and national meetings in relation to clinical trials as appropriate.
Work is managed rather than supervised.
Accountable for own actions, manager is available for reference.
Manages own workload.
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