Clinical Trials Assistant

2 weeks ago


Manchester M BX, United Kingdom The Christie NHS FT Full time £20,000 - £32,000 per year

DUTIES AND RESPONSIBILITIESThe specific responsibilities will depend on the requirements of each team, but mayinclude: Act as a point of contact for the Research and Development core team, studysponsors, clinical research organisations and specific research teams,communicating directly with them regarding data queries, monitoring visits and otherenquiries relevant to general trial conduct.Assist with the general administrative duties associated with the set up and initiationof rials within an assigned team, under the supervision of the Senior Clinical TrialsCoordinators.Assist with completion of activity logs to enable invoices to be raised. Maintaininvestigator site files and essential documentation in accordance with ICH-GCP andTrust 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 ClinicalTrials Coordinators.Provide administrative support to the Clinical Research Nurses and PrincipalInvestigators for safety reporting in accordance with protocol requirements, under thesupervision of the Senior Clinical Trials Coordinators.Complete team reporting mechanisms (i.e. recruitment activity logs, patient visitlogs, costing spreadsheets, case report form trackers and electronic proformas).Assist the Clinical Trials Coordinators with the development of trial workbooks forreview by the lead Clinical Research Nurse and Principal Investigator.Ensure collection of clinical case notes for all patients, so that these are available asneeded, for monitoring and audit purposes.Complete case report forms as per sponsor requirements and liaise with clinical trialmonitors to ensure the data sent is valid and their requirements are met at sitemonitoring visits. This will be under the supervision of the Senior Clinical TrialsCoordinators.Liaise with internal and external NHS staff regarding case notes, data collection,archival tumour blocks, mortality data, and other general trial activities, which may beconfidential and sensitive in nature.Arrange shipping and delivery of relevant trial data and documents includingimport/export of tumour blocks, ECGs and copy scans.Arrange team and trial related meetings as required, producing minutes in a timelymanner.Ensure that data is available and up to date for any meetings related to a clinical trialin 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 managerial representativesfrom the Research Division to contribute to the smooth running of the patientrecruitment teams.

Demonstrates the agreed set of values and accountable for ownattitude and behaviour.



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