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Senior Trial Co-ordinator
3 weeks ago
Key Responsibilities Obtain relevant department approvals for studies, review of Clinical requirements will be performed by the supporting department providing this service Complete and submit the appropriate ethics and RM&S forms for study site approval Ensure appropriate contract is obtained, agreed and signed by all relevant trust departments e.g. legal, RM&S. Coordinate study initiation meetings Work closely within the research team, organising follow up visits and investigations as requested in accordance with trial protocol as appropriate In liaison with the research team facilitate and collate relevant documentation and equipment for each study visit including source data forms, questionnaires, investigation request forms, blood/tissue collection equipment etc. as outlined in the study protocol Accurately transcribe trial information from source data into Case Report Forms (CRFs) Acquire additional clinical trial data from medical notes, hospital computer systems, GPs and external hospitals and organisations Be responsible for quality control, checking validity and completeness of data to provide including ensuring that accurate follow up data is provided to the study sponsor in accordance to protocol requirements.
Ensure accurate and safe filing/storage of study documentation and samples in accordance with ICH GCP Maintain sufficient stocks of documentation and equipment required for clinical trials (e.g. case report forms, blood sample kits) Preparation and coordination of monitoring visits and their follow up Ensuring agreed recruitment metrics are achieved within the agreed timeline Identify barriers to participation in trials and develop strategies with clinicians, Trusts and others to overcome these barriers. Publicising current trials to encourage new participants to join, and to maintain enthusiasm amongst existing participants by appropriate methods - mainly personal letters and the production of regular newsletters for specific projects. Clinical In conjunction with other members of the healthcare team assist in the informed consent procedure.
Assess patients throughout their time on the trial and during follow up, documenting all relevant information to monitor treatment toxicity/side effects and ensures changes to treatment as required by the protocol. Under the guidance of the principal investigator To undertake venepuncture as necessary and organise/undertake spinning. To undertake clinical tasks e.g. assisting procedures, vital signs, urine testing, 12 lead ECGs and calculations.
To act on the results of these tasks as appropriate under direction of the clinical team To work with clinical teams to arrange relevant investigations e.g. Radiology scans throughout the trial. To act as a resource for patients and their families, assuring that all communication and patient contact is in accordance with relevant clinical standards and always maintains an appropriate staff/patient relationship. To record and report serious adverse events according to regulatory and MYTT policies.
Resources and Finance Critically examine working practices within the department to identify cost improvements measures and develop/implement action plans To maintain the record of premium rate activity on the definitive list (E roster) The post holder will ensure the proper use of the Trusts resources such as stationery, telephone usage, photocopying and other consumables in the course of business, ensuring mínimal waste and mínimal cost Monitoring and controlling the use of resources through effective systems of stock control. Lead negotiation with PIs/consultants/lead research nurse and the study team, to agree appropriate distribution of study specific cost. Populate the finance spreadsheet according to study specific income and ensure invoices are raised according to study contract. Monitor study income and ensure patients expenses are reimbursed Archiving Facilitate the secure storage of study documentation in accordance with ICH GCP and Research Governance Managerial / Training Provide advice and training for all members of the research team on the legislation and process of running clinical trials, including other hospital staff in their preparation and submission of personal research projects.
Keep up to date with changes in regulations, e.g. the EU Directive and its implications and how these impact on research processes e.g. ethical submissions, in order to ensure that the studies are run within the Research Governance framework Deputise for the Senior Research Nurses in providing supervisory support and advice to the research team, undertake appraisals and be involved in the recruitment process as required Organisational Responsibilities To maintain the confidentiality of the Trust in respect of patient and staff information obtained at all times, and use such information only as authorised for specific purposes. Report any concerns about the use of such information to the senior manager.
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