The specific responsibilities will depend on the requirements of each team, but may include: Act as a point of contact for the core Research and Development team, study sponsors, clinical research organisations and specific research teams, communicating directly with them regarding data queries, monitoring visits and other enquiries relevant general trial conduct. Timely set up and initiation of source data workbooks within an assigned team, under the guidance of the Senior Clinical Trials Data Coordinators for review by the lead Research Nurse and ensure version control is maintained. Track all payments throughout each clinical trial including completion of activity logs ensuring that all research activity is recorded to facilitate full cost recovery. Assist with the maintenance of the investigator site files and essential documentation (filing consent forms and enrolment forms and completing patient logs) in accordance with ICH-GCP and Trust SOPs to ensure they are kept inspection ready at all times.
Responsible for keeping trial folders, including blood results and laboratory requisition forms up to date in accordance with the studys standard operating procedure. Complete team reporting mechanisms (i.e. recruitment activity logs, patient visit logs, costings spreadsheets, CRF trackers, electronic proformas, serious adverse events trackers, data entry metrics trackers and workbook trackers). Ensure collection and tracking of clinical case notes for all patients, so that these are available as needed, for monitoring and audit purposes.
Ensure that data collected for all trials meets protocol requirements and is complete and accurate. To check the validity and completeness of research data collected within the Trust and take action to obtain or correct missing or contradictory data. Complete case report forms as per sponsor requirements to meet data entry deadlines stipulated in the clinical trial protocol and/or contract. Liaise with clinical trial monitors to ensure the data sent is valid and their requirements are met at site monitoring visits.
To resolve queries by initiating correspondence or direct contact with the research nurses/clinicians and other relevant health care professionals ensuring that reporting timelines are met. Support the clinical research nurses to ensure that reports of serious adverse events are returned to co-ordinating centres/sponsors within the standard time frame. To advise senior members of the team as appropriate, of any concerns relating to protocol adherence, data quality, handling of confidential data or meeting timelines. Completion of clinical trial specific databases with data from various sources such as questionnaires, hospital records and other electronic and paper sources.
Liaise with internal and external NHS staff regarding case notes, data collection, archival tumour blocks, mortality data, and other general trial activities, which may be confidential and sensitive in nature. To ensure confidentiality and security of patients data at all times, particularly when transferring data outside of the Trust. Arrange shipping and delivery of relevant trial data and documents including import/export of anonymised data. Arrange team and trial related meetings as required, producing minutes in a timely manner.
Ensure that data is available and up to date for any meetings related to a clinical trial. If required attend project related meetings, investigator meetings (abroad or teleconferences, as necessary) and Site Initiation Visits to convey the relevant information to the study team. Assist with preparation for audit and inspections within assigned teams. Assist Clinical Trial Coordinators with trial document archiving by following the Trusts archiving guidelines.
Undertake general administrative tasks as delegated by managerial representatives from the Research Division ton contribute to the smooth running of the patient recruitment teams.