Clinical Trials Assistant

DUTIES AND RESPONSIBILITIES The specific responsibilities will depend on the requirements of each team,but may include: Act as a point of contact for the Research and Development core team, study sponsors, clinical research organisations and specific research teams, communicating directly with them regarding data queries, monitoring visits and other enquiries relevant to general trial conduct. Assist with the general administrative duties associated with the set up and initiation of trials within an assigned team, under the supervision of the Senior Clinical Trials Coordinators. Assist with completion of activity logs to enable invoices to be raised. Maintain investigator site files and essential documentation in accordance with ICH-GCP and Trust SOPs to ensure they are kept inspection ready at all times.



Assist with the processing of trial amendment submissions in accordance with ICH-GCP and Trust SOPs and timelines, under the supervision of the Senior Clinical Trials Coordinators. Provide administrative support to the Clinical Research Nurses and Principal Investigators for safety reporting in accordance with protocol requirements, under the supervision of the Senior Clinical Trials Coordinators. Complete team reporting mechanisms (i.e. recruitment activity logs, patient visit logs, costing spreadsheets, case report form trackers and electronic proformas).



Assist the Clinical Trials Coordinators with the development of trial workbooks for review by the lead Clinical Research Nurse and Principal Investigator. Ensure collection of clinical case notes for all patients, so that these are available as needed, for monitoring and audit purposes. 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. This will be under the supervision of the Senior Clinical Trials Coordinators Liaise with internal and external NHS staff regarding case notes, datacollection, archival tumour blocks, mortality data, and other general trial activities, which may be confidential and sensitive in nature.



Arrange shipping and delivery of relevant trial data and documents including import/export of tumour blocks, ECGs and copy scans. 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 in collaboration with the Senior Clinical Trials Coordinators. Attend project related meetings, investigator meetings (abroad or teleconferences, as necessary).



Assist with general preparation for audit and inspections within assigned teams, under the direct supervision of the Senior Clinical Trials Coordinators and lead Clinical Research Nurse. Assist with trial document archiving by following the Trusts archiving guidelines. Ensure that office/ trial related supplies are adequate and assist with the ordering process. Undertake general administrative tasks as delegated by managerialrepresentatives from the Research Division to contribute to the smooth running of the patient recruitment teams.



Demonstrates the agreed set of values and accountable for own attitude and behaviour.