NHS Jobs
Location
Ashton Under Lyne, Greater Manchester | United Kingdom
Job description
Research: Supporting the R&I team with all aspects of clinical trials administration,according to Good Clinical Practice (GCP), standard operating procedures(SOPs) and Trust policies. Maintain local records for all trials, including the set-up and maintenance ofsite files, through to appropriate archiving. Help facilitate the achievement of timeline targets in trial set-up, including the management of R-PEAK related administrative tasks. Ensure version control of all essential documents, including the appropriate and timely dissemination of these to study leads. Liaise between site staff of all levels and Sponsors to arrange site initiation and monitoring visits. Assist clinical trial monitors in site visits, arranging space and access toappropriate files and systems. Build and maintain good working relationships with colleagues, R&I staff,clinical departments and all research partners. Assist in monitoring levels of patient recruitment by recording screening and recruitment to trials and providing this data to the Clinical Research Officer. Processing of Case Reporting Forms (CRFs) and securely sending toSponsors as required by agreed methods. Processing of consent forms and other paperwork as required, includinguploading research related materials to participants electronic patient record i.e., PARIS. Manage the Participant in Research Experience Survey (PRES) within thedepartment, including inviting research participants to participate via letter or telephone. Print research related materials i.e., recruitment packs, promotional materials, for research staff within the department. Maintain study related folders electronically within the department. Input research related data into database management software whenrequired i.e., REDCap. Prioritise and manage data queries to resolution in a timely manner. Maintain effective filing systems, including Excel spreadsheets and otherelectronic documents. Ensure accurate R&I information is on research documentation i.e.,Participant Information Sheets in advance of printing. Attend training relevant to the Clinical Trials Administration role, including Sponsor specific training. Clinical: Ensure a system is in place to track protocol trial visits and enable datacollection points to be met. Use judgement when processing case report forms (CRFs) and data queries -complete where appropriate and refer to the research practitioner / study lead as required. Ensure that patient concerns are dealt with sensitively and confidentially,referring them to the appropriate member of the clinical team as necessary. Send out appropriate correspondence to patients such as invitations toparticipate in research. Type up and post out study related letters to participants, GPs, and othercontacts, as required. Liaise with GPs to gather any clinical information required for the participation in research.Leadership and Management: Manage lone working within the department of research delivery staffundertaking home visits. Maintain the R&I Departments intranet page, ensuring that all currentresearch studies are advertised, and the information is accurate. Communicate clearly with colleagues, keeping the team updated on thingssuch as trial management workload, monitoring visits, and passing onmessages and emails appropriately. Lead on the day-to-day trail administration for the team, flagging any issues or barriers to this with the Clinical Research Officer. Manage trial supplies, including venepuncture materials, requesting morebefore they run out. Ensure that office supplies are adequate, ordered and obtained for thesmooth running of the office. Help train appropriate staff on the use of any local trial administrationprocesses, systems, or IT packages. Attend, contribute, and take minutes for all department related meetings held internally and externally. Answer telephone calls within the department and take accurate messages for colleagues in a timely manner. Assist the research delivery team with any additional administrative tasks as required. The post holder is expected to be able to prioritise assigned tasks and act on own initiative. Education: Keep up to date with all mandatory training, both for Trust and researchrequirements, and help identify activities towards your own professionaldevelopment. Maintain research relevant training records for the department, such as Good Clinical Practice certificates and Research CVs, and request updated versions when required. Share knowledge with the team and help them with any required training in trial administration. Professional: Adhere to all relevant legislation, policies, SOPs, and protocols includingconfidentiality, data protection, information governance and researchgovernance. Monitor workload and prioritise accordingly, seeking assistance whereappropriate. Alert any inconsistencies or blank fields in completed CRFs and consentforms before submitting or filing to the relevant research practitioner. Provide accurate data when requested for various performance reports. Assist with the preparation of presentations and reports. Be pro-active in monitoring working practices within research teams,identifying best practice and suggesting any improvements to administrationprocesses.
Job tags
Salary
£25.15k - £27.6k per annum
