Senior Monitor - Cancer Research Clinical Trials Unit - 56787 - Grade 7 - (190004J5)
Cancer Research Clinical Trials Unit
Location: University of Birmingham, Edgbaston, Birmingham UK
Full time starting salary is normally in the range £30,942 to £40,322. With potential progression once in post to £42,792 a year.
Full Time / Fixed Term Contract to 31 December 2020
Closing date 14 November 2019
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.
• 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, taking into account 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 in 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.
• 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.
• 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.
Further particulars can be found here: http://www.download.bham.ac.uk/vacancies/jd/MDSFPs.pdf
Informal enquires can be made to Sarah Bowden email: email@example.com
Valuing excellence, sustaining investment
We value diversity at The University of Birmingham and welcome applications from all sections of the community
Cancer Research Clinical Trials Unit, Ground Floor
Robert Aitken Building, Vincent Drive The University of BimringhamEdgbaston
Birmingham B15 2TT
: Cancer and Genomic Sciences
: 16.10.2019, 7:00:00 PM
Grade (for job description): Grade 7
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