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Detailed job description and main responsibilities

• Assist with the acquisition and distribution of relevant trial documentation/equipment.

• Provide assistance in the preparation and submission of documentation for Ethical Approval and the NIHR CSP and EDGE process

• To establish trial site files for each trial in accordance with ICH-GCP and research governance.

• To transcribe/export data from medical records (paper or electronic) to CRF’s (paper or electronic) as required by the study protocol

• Facilitate the secure filing and storage of study documentation in accordance with ICH- GCP and Research Governance and conduct quality assurance of documentation

• Take responsibility for liaising with clinical trials units/study sponsors regarding data queries and for checking and resolving data queries

• Have a solid understanding of the application of ICH GCP Guidelines, the EU Directive on Clinical Research and Research Governance

• Maintain accurate patient trial documentation, complete Case Record Forms, including the use of electronic data capture systems and ensure relevant information is recorded in patients’ medical notes

• Ensure safety data is reported to required SOPs and study protocols, and reports sent in a timely manner

• To ensure safe and appropriate storage of specimens in accordance with the trial protocol and in conjunction with specialist teams

• To record and report any adverse and serious adverse events according to trial protocol and local procedure.

• Contribute to effective communications within  the  CRN  East  Midlands,  including preparation and delivery of regular presentations and reports.

• Establish and maintain effective working relationships with all relevant organisations and individuals, including member NHS Trusts, other NIHR Clinical research networks and other providers of NHS services within the CRN, Clinical Trials Units, Industry, and NHS commissioners

• As a new post holder, training will be provided for the key aspects of this role, and a period of induction identified, however, the post holder will be expected to take advantage of opportunities to upgrade their skills and to attend meetings and workshops to enhance their knowledge

• Identify personal educational needs associated with participation in current clinical trials and ensure these are effectively communicated to the Research Manager. Participates in the development of an agreed personal development plan to meet identified needs.

• Ensure safe standards of practice through identification of areas of risk associated with participation in clinical trials. Ensure clinical trial protocols and appropriate professional guidelines are adhered to.

• Participate in the implementation of research practice standards.

• Responsible for remaining adequately informed of clinical trials, R&I activity and the Trust by attendance at team brief and using other appropriate forms of communication.

• To undertake mandatory training as required by the individual Trusts and additional clinical, research and IT training as required by the research studies

• Work to SOP’s, applicable regulatory requirements and laws as per required and

• Manages a personal caseload of clinical trials and patients independently with minimal supervision/mentoring from Principle Investigators/senior research nurses/team leaders

• To ensure relevant approvals are in place prior to commencing each trial

• To ensure all work is undertaken in line with the research protocol, ICH-GCP and Research Governance guidelines

• To act as one of the primary points of contact for clinical trials patients/ parents

• To educate other staff as to the responsibilities of the role and function of the research team and disseminate information on specific studies

• Observe patients and monitor treatment/toxicity side effects; escalating findings accordingly

• Identifies, screens and recruits patients for the clinical trial using agreed protocols in accordance with ICH-GCP and Research Governance

• Provides education and support for patients in research trials

• Work with the lead clinician to evaluate clinical trial proposals, identifying potential patient populations and evaluating cost implications of the trial.

• Work with the Ethics and Governance team to ensure all clinical trial documentation has appropriate ethical committee and Trust approval providing feedback to the lead clinician and research directorate.

• Participate in set-up/initiation/monitoring visits, site audits and study close-down meetings carried out by sponsoring organisations and regulatory authorities

• Provide on-going audit reports as required by the trial protocols and Research & Innovation department/ethics committee

• Responsible for resolving data queries raised by sponsoring organisations

• Demonstrates commitment to the role of patient advocate for patients and families considering or participating in clinical trials

• To provide mentorship and supervision for other research professionals and staff within and outside the department

• Act as a resource for ward based nurses wishing to undertake research once competencies have been achieved

• Responsible for assisting with the completion of study costing templates along with assisting with invoicing and the recovery of income for commercial research as per financial contract agreement

• Act as a role model for excellence in research

• Management and co-ordination of specified trials and take responsibility for :

  • Organisation of any necessary tests and investigations as detailed within the   protocol

  • Sample preparation (e.g. blood, urine, tissue and faecal samples): retrieval, centrifuging, pipetting, slide making and preparation for storage, liaising with the hospital and external laboratories when appropriate.

  • Maintaining logs of stored samples and freezer temperatures

  • Maintaining adequate stock levels of sample kits

  • Organising the logistical aspects of diagnostic specimens, packaging, and shipment, including handling of dry ice

  • Organising and completing follow up assessments including toxicity, Quality of Life assessments and telephone assessments.

  • Resolving data queries raised by sponsoring organisations

  • Archiving all study related material including patient’s notes after study closure

  • Reporting and submitting of Serious Adverse Events (SAEs) from this site within stipulated timeframes to sponsor organisations and the Research and Innovation Office

  • Tracking Serious Unexpected Event reporting

  • Maintaining and updating study specific site files

  • Notifying General Practitioners of their patient’s involvement in a clinical trial

please see job description/person specification for full details on the role.