• Job Description

  Req#: 1665

  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 £34,980 to £44,263, with potential progression once in post to £46,974

  Grade 7

  Full Time, Fixed Term contract up to 30 September 2028

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

  Closing date: 14th September 2023

  Interviews will take place on 5 October 2023

  UK and Global Travel might be required for this role

  
  
  Role Summary

  The key responsibility of the Senior Monitor is to ensure appropriate on-site monitoring of the CRCTU trials portfolio (covering both adult and paediatric phase I-IV trials) is performed throughout the UK and other countries, thereby ensuring that a trial is run following the trial protocol and in accordance with current regulatory, ethical, and quality standards. This will include overseeing the day-to-day management of a team of Monitors. The Senior Monitor is also actively involved in setting up and managing the monitoring of international trials to the appropriate quality standards.

  Main Duties

  • Manage CRCTU’s portfolio of trials with respect to on-site monitoring; maintain oversight of trials in development to allow for workload forecast, provide costings for on-site monitoring at the grant proposal stage and ensure Quality Management Plans (QMPs), covering the degree of on-site monitoring scheduled for a trial) are appropriately set up and are followed within the Quality Management Team throughout the duration of the trials.
  • Manage the monitoring of international trials where the CRCTU has taken on the Sponsor duty for overseeing monitoring. For this, the post holder will have specialist knowledge in the field of monitoring, including international quality standards relating to monitoring. During trial set up and throughout the trial, assess abilities of the coordinating centres based outside the UK (national coordinating centres) with regards to in-house and on-site monitoring, identify discrepancies against the CRCTU Quality Management System (QMS) and ensure discrepancies are dealt with, e.g., by developing and providing national coordinating centres with relevant tools/processes to ensure quality standards are of same level across all participating countries. Provide ongoing training on on-site monitoring procedures to national coordinating centre staff. Review on-site monitoring visit reports, and action on any issues that have not been dealt with appropriately by the national coordinating centre. Feedback to the CRCTU Trial Management Team and other stakeholders with regards to performance of the national coordinating centres.
  • Managerial responsibility for junior staff (Monitors) with respect to day-to-day management, motivation, and support of the staff, including supervision, work allocation, problem solving (this will require a full understanding of the CRCTU monitoring procedures in order to provide clarification to other staff) and monitoring performance. Recruit, train and take responsibility for the Monitors. Provide feedback to Team Leader with regards to planning projects across the Monitors, considering workload, abilities and personal development of individual Monitors.
  • Focussing on the complex trials and/or trial sites, 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. Identify issues (e.g. protocol or Good Clinical Practice (GCP) non-compliance) and suggest corrective action to site personnel. Prepare formal reports detailing issues and actions to be taken. Contribute to the assessment of suspected major and/or critical findings or serious breaches of Good Clinical Practice (GCP) and/or protocol and assist, and when required take a lead, in reporting serious breaches to the MHRA. Liaise with members of the Trial Management Group to share any recurrent trial related errors and issues and suggest ways of dealing with any issues raised at sites. Assist in set-up and initiation of trials and participating sites, including review of trial specific documents, including protocol and Case Report Form, performing initiation assessments, and providing on-site training where required on trial procedures and completion of trial documents. Periodically conduct monitor visits alongside the Monitors to review their progress/training needs or where additional experience is needed.
  • Contribute to the development of monitoring strategies and their implementation in the CRCTU. Collaborate on relevant projects with colleagues outside the CRCTU (e.g. within the University of Birmingham, CR UK or other UK Clinical Trials Units). Ensure that new skills, knowledge, and best practice are disseminated appropriately internally and externally. This will involve presentations, working group membership and provision of training.
  • Provide expert in-house up to date answers to day-to-day queries from CRCTU staff members regarding trial quality management, in-house and on-site monitoring and provide cover for the Quality Assurance Manager.
  • Be able to use own initiative to solve trial quality management and staffing problems. In relation to monitoring the post holder would be expected to review procedures, taking action in amending any procedures that are no longer fit for purpose, recommending, developing and implementing new procedures, and training all staff in new procedures. To be responsible for future evaluations and validation processes.
  • 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, the Quality Assurance Manager and other senior staff (as appropriate) and suggest ways of dealing with the issues. Identify and report any major or critical findings or suspicion of fraud or misbehaviour as per CRCTU procedures.
  • Responsible for keeping abreast with current legal requirements, internationally accepted standards and developments in the professional field. Undertake training as required for the post, at the discretion of the Quality Assurance Manager.
  • Help to further develop and maintain the CRCTU QMS by being a member of appropriate SOP Writing/Review Groups, performing training on relevant SOPs and related documents. Assist the Quality Assurance Manager (where required) to prepare formal reports on audits and inspections (e.g. MHRA inspection dossier, CR UK Progress reports). Conduct audit checks following pre-defined audit plans and as per CRCTU SOPs to assess CRCTU staff’s adherence to regulations and CRCTU SOPs, prepare reports and provide feedback to the relevant CRCTU staff.
  • Any other duties commensurate with the grading of the post
  • Maintain confidentiality.
  • Promotes equality and values diversity acting as a role model and fostering an inclusive working culture.
  • 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.

  Person Specification

  Knowledge and Skills

  • Proven knowledge of the international guidelines that govern clinical trials specifically with regard to monitoring.
  • Effective communication (both written and verbal), negotiation, presentation, time management and interpersonal skills.
  • Ability to meet the travel needs of the post in the UK and further afield on occasion. Overnight stays between visits are required sporadically (2-3 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.
  • Proven ability to work to strict deadlines.
  • Must be able to work independently and as part of a team.
  • 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.

  Qualifications and Experience

  • A higher degree in a relevant biomedical or associated subject or a graduate with extensive experience within a clinical trial environment.
  • Experience of in-house and on-site monitoring of clinical trials.
  • Previous experience of audit would be an advantage.
  • Experience supervising staff members.

  Dimensions

  Staffing

  Senior Monitors act as first line managers to typically 2-4 Clinical Trials Monitors (academic-related grade 6). They report to the Quality Assurance Manager.

  Financial

  Senior Monitors estimate expected levels of monitoring and calculate associated costings for on-site monitoring at the research grant application stage.

  Customer

  Senior Monitors are responsible for managing the CRCTU’s portfolio of trials with respect to on-site monitoring. As such they work closely with senior members of trial management staff at CRCTU to provide costings for on-site monitoring and to maintain oversight of trials in development.

  Senior Monitors may personally be responsible for monitoring a small number of trials (i.e. act as the trial Monitor) as well as providing specialist advice and guidance on all clinical trials within their portfolio. They are also actively involved in setting up and managing the monitoring of international trials, working with national coordinating centres based outside the UK. Therefore they come into contact with a large number of internal and external customers.

  Operational

  As a member of the Quality Management Team Senior Monitors are expected to make a contribution to the writing of standard operating procedures (SOPs) and provide training on relevant SOPs. In particular they are responsible for ensuring monitoring procedures are fit for purpose and for evaluating and validating new processes.

  Senior Monitors are also expected to conduct internal audits to assess adherence to regulations, assist in the preparation of formal reports on audits and inspections and encourage the sharing of best practices across sites and within the CRCTU.

  Clinical trials are highly regulated and the role of the Senior Monitor is to ensure appropriate on-site monitoring of the CRCTU trials portfolio is performed, thereby ensuring that each trial is conducted in accordance with the protocol, Good Clinical Practice, and the applicable regulatory requirements.

  Senior Monitors represent the unit in a professional capacity at local, regional and national and international meetings and fund raising events.

  Planning and organising

  Senior Monitors are responsible for managing the CRCTU’s portfolio of trials with respect to on-site monitoring and for the individual Monitors performing the monitoring. They may also be personally responsible for monitoring.

  Senior Monitors will need to plan and organise their own workload, and that of the Monitors they are responsible for. Typically Senior Monitors are informed of new trials at the grant application stage by the Quality Assurance Manager or directly from the trial management teams. They are required to maintain oversight of trials in development and to assign trials to Monitors during the early stages of trial set-up. During the trial Senior Monitors will ensure that the expected number, frequency and timing of visits as documented in the quality management plan are conducted by the Monitor and will periodically conduct monitor visits alongside the Monitors to review their progress/training needs or where additional experience is needed. Distribution of trials across the Monitors will need to be periodically reviewed to ensure adequate resources are available. Hence Senior Monitors need to be organised and able to implement effective methods of planning and oversight.

  Senior Monitors 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. This will include ensuring the appropriate internal escalation processes are followed and any corrective/preventative action is implemented.

  Problem solving and decision making

  • without reference to others
    • The Senior Monitor would be expected to solve all day-to-day issues relating to monitoring without reference to others. This involves referring to the CRCTU QMS, appropriate internationally accepted standards, liaising with Trial Management Team members from within the CRCTU and colleagues outside the CRCTU. The post holder would also be expected to plan and execute any internal audits/quality checks and deal with minor staffing issues without reference to others.
  • after consulting others
    • The Senior Monitor would be expected to work with the Quality Assurance Manager when deciding on the seriousness of findings noted during internal audits. In addition, the Senior Monitor is expected to liaise with the Quality Assurance Manager with regards to any major performance/quality issues noted for the national coordinating centres in international trials. Finally, the Senior Monitor would be expected to report to the Trial Coordinator when during a monitoring visit any issues are noted that have not been identified before. These would typically involve medical issues regarding patient enrolment and patient treatment.
  • or that would be referred to someone else.
    • Any major or critical findings noted during a monitoring visit or internal audit should be referred to the appropriate staff members as per CRCTU SOPs. Any major staffing problems should be referred to the Quality Assurance Manager. Any newly identified major changes required to the CRCTU QMS should be referred to the Quality Assurance Manager.

  Internal and external relationships

  Quality Assurance Manager

  • Supply regular updates on planned vs. actual monitoring visits across the team, audits and/or quality checks. Report findings/issues relating to monitoring, GCP and/or the CRCTU QMS, and provide suggestions for resolution. Required: reporting, presentation, and communication skills.

  Senior management

  • Provide feedback on internal audits. Required: reporting and presentation skills.

  Hospital staff, including but not limited to physicians, research nurses and pharmacists

  • Provide training to the staff members. Inform staff of latest developments within the trial. Discuss findings/issues noted during a monitoring visit and work towards resolution. Required: presentation, communication, interpersonal and negotiation skills.

  Colleagues outside the CRCTU

  • Collaborate on relevant projects. Required: presentation, reporting, communication, time management skills.

  Trial Management Group

  • Liaise with members of the Trial Management Group to prepare for on-site monitoring including generating costings. Inform the Trial Management Group of the most important and relevant issues noted during monitoring visits and provide suggestions for resolution of the issues. Feedback on performance of national coordinating centres for international trials. Required: reporting, presentation, and communication skills.

  CRCTU staff

  • Provide feedback on trial documentation (e.g. protocol). Work with CRCTU staff during internal audits. Provide feedback on audit findings in a constructive way and share best practices. Facilitate staff training on policies, SOPs and/or tools. Required: presentation, communication, interpersonal and negotiation skills

  Further particulars can be found here

  Informal enquires can be made to Katie Stant email: K.E.Stant@bham.ac.uk

  Valuing excellence, sustaining investment

  We value diversity and inclusion at the University of Birmingham and welcome applications from all sections of the community and are open to discussions around all forms of flexible working .

• About the company

  The University of Birmingham is a public research university located in Edgbaston, Birmingham, United Kingdom.

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