Position Details

Cancer Research (UK) Clinical Trials Unit, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences

Location: University of Birmingham, Edgbaston, Birmingham UK

Full time starting salary is normally in the range £31,396 to £33,966 with potential progression once in post to £38,205

Grade: 6

Full Time, Fixed Term contract up to July 2026

Closing date: 3rd April 2024

UK and Global travel may be required as part of this role

Hybrid working is possible in line with both CRCTU and University of Birmingham policies

Role Summary

The Monitor is responsible for on-site monitoring of CRCTU trials throughout the UK, the Republic of Ireland and other European countries, to ensure that a trial is run following the trial protocol and in accordance with current regulatory, ethical and quality standards. In addition to performing on-site monitoring, the Monitor supports the trial management team by advising on levels of monitoring, reviewing trial documents, assisting in the development of the trial’s quality management plan and providing advice on issues noted during in-house monitoring.

Furthermore, the Monitor contributes to the work of the wider Quality Management Team, including the writing of standard operating procedures (SOPs), performing training on relevant SOPs and encouraging the sharing of best practices across sites and within the CRCTU.

Main Duties

• Prepare, perform and follow up on on-site monitoring visits following the CRCTU Standard Operating Procedures (SOPs) to assess patient recruitment and compliance with trial procedures and the quality and timelines of the data collection.
  • Plan monitoring visits with the sites in an efficient and (cost-) effective way. Arrange travel to sites and accommodation where required in between visits, ensuring costs are within the trial budget under the guidance and approval of the QA Manager
  • During the monitoring visit, review the trial related documents, perform source data verification and visit other departments involved in the trial such as pharmacy
  • Raise any discrepancies, issues or concerns with the site staff and use own initiative to resolve issues locally
  • Where appropriate, provide (additional) training to the site staff
  • Write a monitor visit report and follow-up letter to the site confirming details of what was done, agreed and discussed, and any problems or remaining queries to be addressed
  • Follow up all outstanding queries with the site until resolution
• Liaise with members of the Trial Management Group to:
  • Share any recurrent trial related errors and issues
  • Suggest ways of dealing with any issues raised at sites
  • Assist in the writing of mail shot documents and newsletter articles to address any issues
  • Help prepare/update forms, templates, checklists, documentation, reports etc. as needed for use at sites
• Assist in set-up and initiation of trials and participating sites, including:
  • Provide assistance in developing the Quality Management Plan
  • Assist with the design of database queries/reports to provide documents required to effectively prepare and perform monitoring visits
  • Review trial specific documents, including CRF and protocol
  • Perform initiation assessments and provide on-site training where required on trial procedures and completion of trial documents
• Identify and report any major or critical findings or suspicion of fraud or misbehaviour as per CRCTU procedures.
• Be proactive in further developing ways to improve the quality of trials. Report frequently occurring issues related to regulations, ethics and quality standards to Trial Coordinators and QA Manager, and suggest ways of dealing with the issues. Encourage sharing of best practices across sites and within the CRCTU, and ensure best practices are reflected in the Quality Management System.
• Conduct audit checks following pre-defined audit plans and as per CRCTU SOPs to assess CRCTU staff’s adherence to regulations and CRCTU SOPs and provide feedback to the relevant CRCTU staff.
• Help to further develop and maintain the CRCTU QMS, including being a member of appropriate SOP Writing/Review Groups, performing training on relevant SOPs and related documents and assisting the Quality Management Team where required.
• Keep up to date with current research literature and developments in both the professional field and the disease site speciality. Undertake training as required for the post, at the discretion of the QA Manager.
• Maintain confidentiality.
• Support the delivery of clinical research in accordance with Good Clinical Practice (GCP), the Declaration of Helsinki, applicable legislation (including, but not limited to, the Medicines for Human Use Clinical Trials Regulations, Data Protection Act 1998, Human Tissue Act), the Research Governance Framework for Health and Social Care, Caldicott principals, and applicable NHS Trust and University policies and procedures, (including, but not limited to the University’s Data Protection Policy, Information Security Policy and Code of Practice for Research) in order to protect the research subject and the quality of each study.
• Promotes equality and values diversity acting as a role model and fostering an inclusive working culture.

Required Knowledge, Skills, Qualifications, Experience

• A first degree in a relevant biomedical or associated subject.
• Experience in a clinical research environment in a research management and governance setting.
• Knowledge of the governance and legislative framework for conducting clinical trials, including Good Clinical Practice.
• Understanding of medical terminology.
• Project management experience.
• Effective communication, negotiation, presentation and interpersonal skills.
• Excellent organisational and time management skills.
• Ability to travel easily in the UK and further afield on occasion. Access to personal transport (i.e. car) and current (full) driving licence is required following training period for unaccompanied visits to sites. Overnight stays between visits may be required occasionally (3-4 times per year) and on occasion trips may include longer stays (up to 4 nights, Monday-Friday only).
• Ability to work on own initiative and problem solve. Capable of taking own decisions to organise the work of a professional team under management guidance.
• Demonstrate a critical and intelligent attention to detail and high standards of accuracy.
• Office management and clerical skills that include excellent word processing and document layout.
• Knowledge of the protected characteristics of the Equality Act 2010, and how to actively ensure in day to day activity in own area that those with protected characteristics are treated equally and fairly.

Dimensions

Customer

Monitors are typically responsible for the monitoring of 8-10 recruiting trials in addition to a number of trials which will be in the set-up phase. As such they can interact with a large number of external customers based at participating sites e.g. consultants, nurses, data managers and pharmacists. The Monitor also works closely with the Trial Coordinator and other members of the trial management team at CRCTU e.g. data managers, trial administrators and statisticians.

Operational

As a member of the Quality Management Team Monitors are expected to make a contribution to the writing of standard operating procedures (SOPs), performing training on relevant SOPs, conducting internal audits to assess adherence to regulations and CRCTU SOPs and encouraging the sharing of best practices across sites and within the CRCTU.

Clinical trials are highly regulated and the role of the Monitor is to ensure the trial is conducted in accordance with the protocol, Good Clinical Practice, and the applicable regulatory requirements. Hence it is important that Monitors have a good understanding of clinical trial regulations and are able to comply with unit policy and procedure.

Planning and organising

A Monitor is employed to perform on-site monitoring for a range of clinical trials, which contribute to the University’s research output.

Trials are assigned to a Monitor by the Quality Assurance Manager or a Senior Monitor, with the day to day management of the Monitor being provided by a Senior Monitor. The Monitor will need to plan and organise their own workload. They are required to plan monitoring visits in accordance with the number, frequency and timing of visits as documented in the quality management plan. Typically visits are booked 4-6 weeks in advance however each trial will have its own monitoring requirements and some trials may require monitoring at shorter notice than others. In addition the Monitor will need to be reactive as problems (e.g. a serious breach of the protocol /Good Clinical Practice) will have to be dealt with immediately and may involve additional monitoring visits at short notice.

The frequency of visits carried out by the Monitor is often dependent on the progress of the trial during set-up and how quickly the trial recruits once it is open. Hence the Monitors have to be able to reprioritise their workload on a regular basis to ensure monitoring requirements are met.

Further particulars can be found here

Informal enquiries to Katie Stant, email: k.e.stant@bham.ac.uk

We believe there is no such thing as a 'typical' member of University of Birmingham staff and that diversity in its many forms is a strength that underpins the exchange of ideas, innovation and debate at the heart of University life. We are committed to proactively addressing the barriers experienced by some groups in our community and are proud to hold Athena SWAN, Race Equality Charter and Disability Confident accreditations. We have an Equality Diversity and Inclusion Centre that focuses on continuously improving the University as a fair and inclusive place to work where everyone has the opportunity to succeed. We are also committed to sustainability, which is one of our values. You can find out more about our work to create a fairer university for everyone on our website .