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Trial Manager
Job Description
Looking for a temporary Trial Manager for a 48-month UK multicentre cluster randomised controlled trial to assess whether ADVANCE-D (a digitally- supported perpetrator intervention) is superior in reducing intimate partner violence (IPV) perpetration compared to usual community justice offender management for men who misuse substances subject to probation/criminal justice social work supervision. Applicants should have demonstrated experience of trial management and co-ordination of multi-centre (mixed-methods) randomised controlled trials from set-up to closure. The Chief Investigator is looking to appoint an experienced trial manager on a temporary basis (initally) to assist with setting up trial processes including ethics application, trial protocol and data linkage applications and agreements.
Key responsibilities
· manage administration for the study, and actively contributing to the research planning and development in partnership with Principal Investigators, Executive and Steering Groups and Study Teams
· be a key liaison with all university departments, relevant ethics and R&D committees, funding bodies etc
· prepare and support meetings, boards, and committees, including the coordination and distribution of briefing documents and background materials, drafting presentations or taking minutes, as required
· ensure all necessary approvals are in place, recruiting sites are initiated, staff are appropriately trained, and recruitment is maximised across all sites ensuring timely recruitment of study participants into studies
· develop working guidelines for the trial as necessary and manage all communications with the Sponsor organisation
· set up and monitor the Trial Master File
Qualifications
1. A degree in a relevant or numerate discipline (e.g. psychology, health services research, criminology, sociology or related discipline)
2. Formal qualification in clinical trials
3. Post graduate qualification with a research methodology element
Skills
1. Experience of working in research or clinical trials studies
2. Proven experience of all stages of a clinical trial from start up to closeout
3. Experience of using complex databases and management information systems
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Key responsibilities
- To support the Lead Invigilator/ Staff Lead in carrying out their duties by attending briefing sessions prior to and following exam sessions as required.
- To assist with setting up the circuit(s): putting out clipboards, sharp pencils, and rubbers inside each station.
- Assist with the set-up of equipment (training will be given for the setting up of props or the resetting of station equipment).
- To assist students before the exam begins, ensuring that all students are correctly located and ready for the exam.
- To invigilate the examination circuits and guide students between stations during the exam.
- Direct examiners, patients, simulated patients to the correct stations.
- Be the first response for examiner questions or concerns, raising issues with the lead invigilator or senior examiner quickly and efficiently.
- To vigilantly monitor the room/allocated area throughout the exam in session whilst not disrupting the candidates; and ensuring a calm environment conducive to supporting students to be successful in their exams.
- To ensure that noise levels on the examination circuit are kept to a minimum and that examination conditions are maintained throughout
- To promptly report any incidents that may impact a candidate's performance to the Lead Invigilator, Circuit Lead (Marshall), OSCE Site Lead, or Senior Examiner.
- To ensure that, at the end of the exam, all iPads and materials are collected and returned to the relevant place according to set procedures as advised by the Lead Invigilator.
Qualifications
N/a
Skills
Experience of Clinical Examination Invigilation
The post holder will primarily manage activities relating to the randomisation service and electronic data capture (EDC) system, such as taking responsibility for user access and password management, data export, circulating documents for signature, receiving and processing Serious Adverse Event (SAE) forms relating to a portfolio of trials, reviewing the content of such notifications and processing them according to regulatory requirements, co-ordinating of King?s Trials Partnership activities and managing document version control and tracking within the KCTU.
Qualifications
Degree level qualification or equivalent professional experience (a subject with either a major health related component e.g. biology, psychology, or of relevance to administration e.g. accounting, business management, NHS management would be desirable
Skills
To act as the main point of contact for approximately 100 clinical trial teams currently using the KCTU randomisation service and electronic data capture system (EDC)
- To process requests for user access to IT systems supporting the KCTU portfolio of trials accurately and promptly, with due care and attention
- Manage activities relating to randomisation and EDC system, keeping accurate auditable records
- To process Serious Adverse Event (SAE) reports in accordance with KCTU SOPs
- Occasionally, to process Emergency Code Break notifications in accordance with KCTU SOPs
- To receive and resolve queries relating to the above during the life of each project
- To provide administrative support to the King?s Clinical Trials Unit Operational Director and Business Manager along with other KCTU staff as needed
- Manage activities of the KCTU in line with KCL policy and procedures and with the Standard Operating Procedures of the Clinical Trials Unit
- To participate in inspections of the KCTU by sponsor auditors, regulatory authorities and others, ensuring key documents are readily available
- To ensure that the KCTU?s website is kept up to date and that the information is accurate
- Responsible for providing a professional, accurate and efficient service to a wide range of people including study teams, colleagues and external agencies
- Ensure compliance with GCP, regulatory legislation and ethical frameworks in respect of working practices
- Liaise with a wide range of internal and external clients to ensure requests for user access to KCTU IT systems are processed swiftly, which will involve explaining complicated procedures on how to obtain access
- Being mutually supportive and covering duties as necessary during colleagues absences and at time of additional pressure, as directed
The above list of responsibilities may not be exhaustive, and the post holder will be required to undertake such tasks and responsibilities as may reasonably be expected within the scope and grading of the post.
MBBS OSCE Invigilation 23rd & 24th April 2025 (08.00 til 13.00 PM) Guys Campus
Key responsibilities
- To support the Lead Invigilator/ Staff Lead in carrying out their duties by attending briefing sessions prior to and following exam sessions as required.
- To assist with setting up the circuit(s): putting out clipboards, sharp pencils, and rubbers inside each station.
- Assist with the set-up of equipment (training will be given for the setting up of props or the resetting of station equipment).
- To assist students before the exam begins, ensuring that all students are correctly located and ready for the exam.
- To invigilate the examination circuits and guide students between stations during the exam.
- Direct examiners, patients, simulated patients to the correct stations.
- Be the first response for examiner questions or concerns, raising issues with the lead invigilator or senior examiner quickly and efficiently.
- To vigilantly monitor the room/allocated area throughout the exam in session whilst not disrupting the candidates; and ensuring a calm environment conducive to supporting students to be successful in their exams.
- To ensure that noise levels on the examination circuit are kept to a minimum and that examination conditions are maintained throughout
- To promptly report any incidents that may impact a candidate's performance to the Lead Invigilator, Circuit Lead (Marshall), OSCE Site Lead, or Senior Examiner.
- To ensure that, at the end of the exam, all iPads and materials are collected and returned to the relevant place according to set procedures as advised by the Lead Invigilator.
Qualifications
N/a
Skills
N/a
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