Clinical Trials Coordinator - Manchester, United Kingdom - The Christie NHS FT

The Christie NHS FT

Verified Company

Manchester, United Kingdom

3 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

DUTIES AND RESPONSIBILITIESThe specific responsibilities will depend on the requirements of each team, but mayinclude: Act as a point of contact for the core Research and Development team, studysponsors, clinical research organisations and specific research teams,communicating directly with them regarding data queries, monitoring visits and otherenquiries relevant to trial set up and general trial conduct.

Set up and initiation of allocated trials within an assigned team, under theguidance of the Senior Clinical Trials Coordinators. Track all payments throughout each clinical trial including completion ofactivity logs and requesting invoices to be raised.

Maintain investigator site files and essential documentation in accordancewith ICH-GCP and Trust SOPs to ensure they are kept inspection ready at all times.

Process trial amendment submissions in accordance with ICH-GCP and TrustSOPs and timelines. Provide administrative support to the Clinical Research Nurses and PrincipalInvestigators for safety reporting in accordance with protocol requirements. Complete team reporting mechanisms (i.e. recruitment activity logs, patientvisit logs, costing spreadsheets, case report form trackers and electronic proformas).

Produce trial workbooks for review by the lead Clinical Research Nurse andPrincipal Investigator for assigned studies and ensure version control is maintained.

Ensure collection of clinical case notes for all patients, so that these areavailable as needed, for monitoring and audit purposes.

Complete case report forms as per sponsor requirements, and liaise withclinical trial monitors to ensure the data sent is valid and their requirements are metat site monitoring visits.

Cross check, confirm data and complete query resolution with sponsors andthird parties in a timely manner.

Completion of clinical trial specific databases with data from various sourcessuch as questionnaires, hospital records and other electronic and paper sources.

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.

Clinical Trials Coordinator

Band 4 April 2024 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 atimely manner. Ensure that data is available and up to date for any meetings related to aclinical trial.

If required attend project related meetings, investigator meetings (abroad orteleconferences, as necessary) to convey the relevant information to the study team.

Assist with preparation for audit and inspections within assigned teams. Assist with trial document archiving by following the Trusts archivingguidelines. Ensure that office/ trial related supplies are adequate and assist with theordering process.

Undertake general administrative tasks as delegated by managerialrepresentatives from the Research Division to contribute to the smooth running of thepatient recruitment Teams.

Demonstrates the agreed set of values and accountable for own attitude andbehaviour