Clinical Trials Assistant

Administrative Management Maintain appropriate control of radiology imaging manuals and essential documentation in accordance with ICH-GCP and Trust SOPs to ensure they are kept inspection ready and accessible at all times. Work in conjunction with CT radiographers and Research Teams to agree priorities for studies in set up and amendments Attend project related meetings, or teleconferences, as necessary, producing minutes in a timely manner. Assist with general preparation for audit and inspections within assigned teams, under the direct supervision of the Clinical Trials Radiographers. Regular requirement to develop or present reports relating to data held in one or more of the research radiology information systems Set up and initiation of allocated trials within an assigned team, under the guidance of the Senior Research Project Manager.

Provide administrative support to the Clinical Research Nurses and Principal Investigators for safety reporting in accordance with protocol requirements. Maintain investigator site files and essential documentation in accordance with ICH-GCP and Trust SOPs to ensure they are kept inspection ready 2at all times. Complete case report forms as per sponsor requirements, and liaise with clinical trial monitors to ensure the data sent is valid and their requirements are met at site monitoring visits. Process trial amendment submissions in accordance with ICH-GCP and Trust SOPs and timelines.

Archive all trial radiology documents following the Trusts archiving guidelines. Information management Maintain the radiology clinical trials database including accurate patient data entry, imaging, invoicing costs for individual patient examinations, and resolution of discrepancies between Trust information systems (CRIS, CWP) for patients taking part in clinical trials associated with radiology. Produce copy scan images for research purposes ensuring GCP and GDPR requirements are followed in the production and transfer of images. Maintain tracking systems i.e.

attendance and appointment stats, copy scan logs, clinical trials database maintenance in response to service needs. Display high level of IT skill in order to navigate the existing databases, electronic health systems and track progress updates and queries within Microsoft Excel. Assist with the processing of trial amendment submissions in accordance with ICH-GCP and Trust SOPs and timelines, under the supervision of the Clinical Trials Radiographers. COMMUNICATION Act as a point of contact for the Research and Innovation core team, external study sponsors, contract research organisations (CROs) and specific research teams, communicating directly with them regarding data queries, monitoring visits and other enquiries relevant to general trial conduct.

Liaise with staff at all levels both internally and externally on a daily basis, answering written and verbal enquiries when necessary, taking action on all matters which can be dealt without further reference. WORKING PRACTICE Contribute to continuous developments and the future development of the radiology clinical trials service. Be pro-active in providing feedback on working practices within the clinical research team. The post holder is expected to use initiative and be able to work independently without close supervision, referring to the Clinical Trials Radiographers.

Be guided by relevant protocols and SOPs, and expected to exercise judgement outside these areas with support from the Clinical Trials Radiographers. PERSONAL AND PEOPLE DEVELOPMENT Maintain professional development whilst evaluating own specialist knowledge with assistance from the assigned line manager, to satisfy the NHS Knowledge and Skills Framework. Participate in Trust-wide education programmes and study days, regional and national meetings and research seminars as appropriate. Any other duties that might be reasonably requested to maintain the smooth running of the service, commensurate with the banding of this role.

PHYSICAL, MENTAL AND EMOTIONAL EFFORT Long periods of time spent using keyboard and VDU to input information and use of VDU for electronic communication. Prolonged concentration is regularly required (e.g. when checking through trial documentation and entering data into spreadsheets). Occasional exposure to distressing circumstances as trial patients are commonly suffering from terminal illnesses.

Incidental interactions with patients