Clinical Trials Coordinator

Job overview

The main purpose of the role is to support the Experimental Cancer Medicine Team with all aspects of clinical trials administration, according to Good Clinical Practice (GCP), standard operating procedures (SOPs) and Trust policies. The post holder will provide support to the Senior Clinical Trials Coordinators and wider Clinical Research Team.

The post holder will assist with the administration of clinical trials from feasibility to archiving including (but not limited to): •    Assist with the efficient and timely set up of clinical trials. •    Assist with the tracking and raising of invoices. •    Manage own workload for daily trial activity including case report form completion and amendment processing to meet internal and external deadlines. •    Assist with quality assurance of all trial related documentation in accordance with relevant legislation and guidelines. •    Assist with preparation for audit and inspections within assigned teams. •    General trial-related communication in accordance with the Data Protection Act.

Main duties of the job

The specific responsibilities will depend on the requirements of each team, but may include:

• Act as a point of contact for the R&I 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 trial set up and general trial conduct.
• Set up and initiation of allocated trials within an assigned team, under the guidance of the Senior Clinical Trials Coordinators.
• Track all payments throughout each clinical trial including completion of activity logs and requesting 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.
• Process trial amendment submissions in accordance with ICH-GCP and Trust SOPs and timelines.
• Provide administrative support to the Clinical Research Nurses and Principal Investigators for safety reporting in accordance with protocol requirements.
• Produce trial workbooks for review by the lead Clinical Research Nurse and Principal Investigator for assigned studies.
• 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.
• Ensure that scans are reproduced in a timely manner for the purposes of the clinical trial and that they are dispatched according to study protocol.

Detailed job description and main responsibilities

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 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 to trial set up and general trial conduct.
• Set up and initiation of allocated trials within an assigned team, under the guidance of the Senior Clinical Trials Coordinators.
• Track all payments throughout each clinical trial including completion of activity logs and requesting 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.
• Process trial amendment submissions in accordance with ICH-GCP and Trust SOPs and timelines.
• Provide administrative support to the Clinical Research Nurses and Principal Investigators for safety reporting in accordance with protocol requirements.
• Complete team reporting mechanisms (i.e. recruitment activity logs, patient visit logs, costing spreadsheets, case report form trackers and electronic proformas).
• Produce trial workbooks for review by the lead Clinical Research Nurse and Principal Investigator for assigned studies and ensure version control is maintained.
• 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
• Cross check, confirm data and complete query resolution with sponsors and third parties in a timely manner.
• 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.
• 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.
• If required attend project related meetings, investigator meetings (abroad or teleconferences, 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 Trust’s archiving guidelines.
• Ensure that office/ trial related supplies are adequate and assist with the ordering process.
• Undertake general administrative tasks as delegated by managerial representatives 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.