This is a full time post offered on a fixed-term basis until 31 August 2019.

Transcription

1 Faculty of Medicine and Health Sciences Norwich Medical School CTU Trial Assistant REF: SC3019 This is a full time post offered on a fixed-term basis until 31 August The Post A Clinical Trial Assistant is needed to work within the Clinical Trial Operations Group of the Norwich CTU (Clinical Trials Unit) ( assisting the Trial Manager to ensure efficient and smooth administrative processes and operation in support of the ARISSA-UK trial, an important study for patients with atrisk asthma who have a higher risk of hospitalisation. The post may also involve supporting other core senior members of the Clinical Trials Unit. Job Description The job description for this posts is attached as Appendix A. Person Specification The full person specification for this post is attached as Appendix B. Informal Enquiries For an informal discussion about the position, please contact Dr Erika Sims, Senior Clinical Trial Operations Manager (E.Sims@uea.ac.uk or telephone ). Norwich Clinical Trials Unit Norwich Clinical Trials Unit (NCTU) has been established by UEA and Norfolk and Norwich University Hospitals (NNUH) to provide an effective platform for the conduct of high quality clinical trials and to provide a forum for training and methodological advancement in trial design, conduct and analysis. This includes developing funding applications, trial design, management, quality assurance, analysis and reporting. The vision is to establish an internationally recognised clinical trials unit to conduct important trials across a broad range of clinical disciplines which influence clinical and research practice and are published in high impact journals, thus enhancing the international research reputation of Norwich Research Park (NRP). Norwich CTU is a key asset for translational research by Norwich Research Park Partners made up of the UEA, NNUH, John Innes Centre, Institute of Food Research,

2 Sainsbury Laboratory and the Genome Analysis Centre. These institutions form an extensive bioscience community which is identifying new ways to improve human health. Norwich CTU is undergoing an expansion, in recognition of its importance to reliably evaluate new treatments and take advantage of a growing pipeline of investigative compounds that can be taken from early to late stage using technology, development and trials expertise across the Norwich Research Park. Norwich CTU is fully registered as a UK Clinical Research Collaboration trials unit and receives National Institute for Health Research (NIHR) CTU support funding to help the CTU in developing and supporting NIHR trials. The Faculty of Medicine and Health Sciences The Faculty of Medicine and Health Sciences (FMH) consists of the following Schools of Study: Norwich Medical School (MED) School of Health Sciences (HSC) The Faculty is led by the Executive Dean of Faculty, working closely with Associate Deans who share responsibility for the areas of Research, Enterprise and Engagement, Learning and Teaching, Postgraduate Research Students and Admissions. Each School of Study is led by a Head appointed from the academic staff within that School. These senior academics, together with the Senior Faculty Manager for the Faculty, the Human Resources Manager and the Faculty Finance Manager, form the Faculty Executive. Each Head of School is supported by a Faculty/School Manager and all Schools are supported by local support staff. In addition, there are function-based hubs which provide the following University-wide services: Admissions, Recruitment and Marketing (ARM); Learning and Teaching (LTS); Postgraduate Research Students, Partnerships and Equality and Diversity (including CRB) (PPE); and Research Services (REN).

3 GENERAL Salary Salary will be in the range 21,220 to 24,565 per annum on Grade 5 of the single salary spine. The normal expectation is that the starting salary will be at the minimum of the advertised salary scale. Starting date The post is available immediately on a full time, fixed-term basis until 31 August Terms and Conditions of Appointment Full details of terms and conditions of employment for Secretarial and Clerical Staff will be made available to the candidate to whom the appointment is offered. Annual Leave Entitlement There is an annual holiday entitlement of 20 days plus statutory (8 days) and customary (6 days) holidays. Superannuation The post is superannuable under the Universities Superannuation Scheme. Disclosure and Barring Service This appointment will be subject to a criminal record check at Enhanced level from the Disclosure and Barring Service. Entitlement to Work in the United Kingdom If you are shortlisted for interview you will be asked to bring to interview original documentary evidence of permission to work in the UK. Candidates invited to interview will be provided with a list of appropriate documents that can be provided as evidence. Please DO NOT provide this with your application. Workers from outside of the EU may be eligible to work in this role subject to their immigration status. However, due to the nature of this role and the level of qualifications required, please note that immigration legislation will not allow the University to apply for a sponsorship certificate for this post. Pre-Employment Health Assessment Appointment will be subject to a satisfactory Pre-Employment Health Assessment to be carried out by the University s Occupational Health Service.

4 APPLICATION AND RECRUITMENT PROCESS Your completed application form should quote reference code SC3019 and be returned by not later than 12 noon on 2 February 2017 in one of the following ways: accessed via the relevant vacancy details at then downloaded in Word format to be completed electronically then saved and sent as an attachment to hr@uea.ac.uk or accessed via the relevant vacancy details from then downloaded in Word format to be completed electronically, then printed and posted to the Human Resources Division, University of East Anglia, Norwich, NR4 7TJ, or accessed via the relevant vacancy details from and downloaded in PDF format and printed, to be completed by hand and returned by post to the Human Resources Division at the address shown above or forms received by post from the Human Resources Division should be completed by hand or typed and returned by post to the above address. Postal applications will not be acknowledged unless a stamped addressed envelope/postcard is supplied. For paper submissions please ensure you add the correct postage to your application pack as failure to do so will considerably delay receipt by this office and may jeopardise your application for this post. Please note that feedback will not normally be provided to those applicants who are not shortlisted for this post. Please note that applications received after the closing date will not normally be accepted. If you are submitting an application by post immediately prior to the closing date please contact the Human Resources Division on to let us know that your application has been posted, and if possible also send a copy by fax to or by to hr@uea.ac.uk in order that we receive these by the closing date. Equal Opportunities Monitoring Form Please note that an Equal Opportunities Monitoring Form must be completed and returned with ALL applications, whether submitted by post or by . If submitted by , the Equal Opportunities Monitoring Form must be sent as a separate document/attachment to the Application Form.

5 The Equal Opportunities Monitoring Form will be detached from the received application before short-listing takes place and will not form any part of either the shortlisting or decision making process. Referees In naming referees in your application, you are requested to give only those who can immediately be approached and one of these must be your current employer, or if not employed your most recent employer. Interviews Candidates who have not heard by 10 February 2017 should assume their application has been unsuccessful. Successful shortlisted candidates may be notified of their interview times by telephone and/or and it is therefore essential you include both of these in your application. Candidates should note that travel and incidental expenses incurred in attending the interview will not be reimbursed. This document is available in alternative formats e.g. large print, disc and on-line. If you need this document in an alternative format please contact us on , fax , or

6 APPENDIX A JOB DESCRIPTION Job Title: CTU Trial Assistant REF: SC2959 Grade: Grade 5 Job Function/Purpose To assist the Trial Manager to ensure efficient and smooth administrative processes and operation to support the ARISSA-UK trial, an important study for patients with at-risk asthma who have a higher risk of hospitalisation. The post may also involve supporting other core senior members of the Clinical Trials Unit. The main duties of the post are to: Assist the Trial Manager in setting up and maintaining filing systems for study documentation and correspondence; both electronic and paper including a regulatory compliant Trial Master File (TMF). Ensuring that the TMF is inspection ready at all times. With the Trial Manager, maintain a close working relationship with investigators and site staff. Ensure prompt and efficient response to queries (daily trouble shooting) from recruiting sites, escalating to Trial Manager, Senior Clinical Trial Operations Manager or Chief Investigator as appropriate. Contribute to CTU trial set-up activities including development and critical review of trial essential documents (e.g. patient information sheet, informed consent form, trial management documents and site file documentation). Assist the Trial Manager with site setup, ensuring that research sites have the appropriate documentation for site activation and have received training on trial procedures. Develop and/or critically review and/or QA: case report forms and other trial specific data management documentation, including working instructions for sites on data management. Ensure that trial specific data management documentation is adhered to. Perform testing of the Study Database prior to release to sites, documenting non performances and following through with the Trial Manager and Data Management Team to resolution. Check and process Case Report Forms received by the CTU, including data entry when required.

7 Check and process SAE forms received by the CTU, including scanning for patient identifiers and redacting any personal information, scanning for completeness of form and following up with sites immediately for missing essential data; ensuring that the SAE flow for confirmation of expectedness and causality and timely clinical review is completed. Enter SAE data into SAE database, close out SAEs, log and file forms in the Trial Master File. Process randomisations Under the supervision of the Trial Managers, ensure compliance with the trial Quality Management and Monitoring Plan which includes remote data monitoring and some on-site monitoring. Perform Central Monitoring through review of data in the trial database as described in the trial specific QMMP. Ensure efficient query management and resolution, quality control, data cleaning and validation. Enter trial information into the Integrated Research Application System, trial safety reports, and other reports including to the Funder, Sponsor and Research Ethics Service. Process and graph/tabulate CONSORT and accrual data. Collate, validate and upload submission of trial accrual data to the UKCRN portfolio and other related third parties. Assist with updating the study website and production of newsletters, regular and ad hoc trial reports and manuscripts for publication as requested. Manage trial supplies and distribution to sites, ensuring that all collaborators are supplied with appropriate materials. Provide general office management, delegating to CTU administrator depending on priorities, to keep operations running smoothly. Undertake general office duties such as maintaining stationery and other similar items, in the absence of the CTU administrator. Contribute to trial team meetings. Contribute to the creation of trial specific working instructions. Arrange trial meetings, preparing agendas and typing minutes. Coordinate communication with the external parties including trial governance committees (Trial Management Group, Trial Steering Committee, Data Monitoring Committee), Funders, Sponsors and ethics and regulatory committees.

8 Provide cross cover to other established Trial Teams in the event of staff absences and assist the Clinical Trial Operations Manager with start-up activities on other newly funded trials, prior to the recruitment of trial staff. Work to Good Clinical Practice (GCP) guidelines on trial conduct and data management and ensure knowledge is kept updated. Follow established policies, procedures, objectives, continuous quality improvement objectives and the Norwich CTU Quality management System.

9 APPENDIX B PERSON SPECIFICATION Post title: CTU Trial Assistant REF: SC3019 CRITERIA Essential Desirable Education, Experience and achievements Skills & Knowledge A good standard of education with a minimum of five GCSEs including Mathematics and English or equivalent qualification or experience. Proven recent experience of working in a busy research or administrative role, independently managing the implementation of tasks and systems. Experience of organising small and medium size meetings, liaising with participants and communicating agenda, background and minutes documents. Experience of maintaining filing systems with the ability to extract and supply information in support of senior colleagues. Demonstrable excellent communication skills in English Language. Experience of supporting a research project or clinical trial. Excellent organisational and time management skills with ability to prioritise competing demands and priorities and meet deadlines. Excellent administrative skills. Excellent time management and organisational skills. Excellent attention to detail. Good IT skills in Microsoft Office applications. Good presentation skills. Relevant further or higher degree. Experience of working within a Clinical Trial Unit or other research environment. Experience of performing on-site or remote monitoring tasks on a clinical trial.

10 Ability to generate accurate data/information from database record systems. General awareness of clinical research and current issues within the UK. Familiarity with Good Clinical Practice (GCP) and/or with Information governance and data protection. Familiarity with LifeRay Content Management System or other Content Management system for updating websites. Experience of clinical trial data collection principles and Case Report Forms (CRF s). Experience of working in a CTU or CRO. Ability to produce work to a consistently high standard, with attention to detail, within tight deadlines and to be able to handle confidential and sensitive information appropriately. Ability to plan and coordinate the communications for, and interactions on, research activities with a large number of many other collaborating sites (GP Surgeries, Research Network offices, collaborating universities and others). Ability to exercise judgement in making decisions (following established procedures) or referring to others. Ability to plan and arrange local travel for self and others. Ability to apply expertise and judgment to verify patient safety and patient rights. Personal Attributes Self-motivated and able to work independently without close supervision. Ability to work in team environment effectively. Ability to promote best practice within the team.

11 Able to work independently and as part of a team. Well organised, methodical approach. Willingness to undertake appropriate training and apply knowledge learnt. Good communication skills. Tenacity to follow actions through to completion. Special Circumstances Normal office hours, flexible working to accommodate longer hours may occasionally be necessary. Willing and able to travel within the UK.