Trial Manager

King's College London

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Job id: 080425. Salary: £51,974 – £59,395 per annum, including London Weighting Allowance.

Posted: 04 December 2023. Closing date: 04 January 2024.

Business unit: IoPPN. Department: Addictions.

Contact details:Professor Gail Gilchrist. [email protected]

Location: Denmark Hill Campus. Category: Professional & Support Services.

Job description

Applications are invited for a 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. We will also conduct a nested process evaluation to explore the implementation, mechanisms of impact, and contextual factors of delivering ADVANCE-D with participants and practitioners The costs and outcomes of ADVANCE-D over and above usual community justice offender management will be compared. Short, medium, and longer-term outcomes for men and their (ex)-partners will be assessed by research interview at 4 and 12-months and via linkage with health and criminal justice records at 24 months.

Applicants should have demonstrated experience of trial management and co-ordination of multi-centre (mixed-methods) randomised controlled trials from set-up to closure, including the supervision and workload allocation of research staff. Applicants must have a PhD or MSc in a relevant field with significant research management experience.

The post holder will be based in the Addictions Department, Institute of Psychiatry, King’s College London to work with Professor Gail Gilchrist and others (from the Universities of Edinburgh, Manchester, Cardiff and York) to lead on trial management and conduct, from set-up to close down of the trial.

The trial will be conducted in London, Manchester, Wales and Scotland.  A researcher will be employed in each of these 4 areas. The trial manager will supervise the Research Associate at King’s College London and oversee the workload allocation of researchers at all trial sites.

The successful candidate will be responsible for trial management including the nested process and economic evaluations and establishing patient follow-up in administrative data, data management, liaising with probation services, and supporting research staff. They will also be responsible for gaining ethical and other governance approvals for the project.

For more detail about the ADVANCE-D Programme:

 https://pubmed.ncbi.nlm.nih.gov/34711276/

 https://app.box.com/s/gjks22jpgt31jzjyr47ul496kusd1wfl

This post will be offered on a full-time, fixed term contract until 31st October 2027.

Key responsibilities

  • Direct reporting to the Chief Investigator
  • Lead the trial coordination, administration, and data management
  • Responsible for trial, registration and conduct
  • Work with the research team and clinical trials unit to develop the trial protocol, trial documentation and gain ethical and governance approvals
  • Organise and conduct site set up and monitoring visits
  • Oversee the day-to-day running of the trial including supervision of research and data management staff at KCL, and the workload allocation of research staff across other sites
  • Monitor and report on trial progress throughout the trial
  • Report safety events to the data monitoring committee
  • Adhere to ethical and governance requirements and ensure staff and other stakeholders are trained in their use and follow procedures
  • Monitor and manage trial budget
  • Carry out other duties appropriate to the grade and role, as directed

Communication & Networking:

  • Establish and maintain good communication between research team, research sites, the funder
  • Coordinate and support the activities of the Trial Management Group, Steering and Data Monitoring Committee, PPI and other research team meetings
  • Provide data for meetings and (interim) reports as required by the Chief Investigator
  • Update the Trial Steering and Data Management and Ethics Committees, the funder and ethics committees as required
  • Liaise with probation services and other key stakeholders, the clinical trials unit and research teams on an ongoing basis

Analysis & Research:

  • Responsible for data management including undertaking regular checks on data quality
  • Develop applications to conduct ‘Names Enquiries’ to link trial participants to routine health, social services, and criminal justice databases
  • Assist with writing manuscripts and reports

Team Work, Teaching & Learning Support:

  • Demonstrate innovation and problem solve solutions
  • Manage the work allocation of other team members
  • Contribute to the day-to-day administrative work of the Department as appropriate to the post.
  • Work effectively with research colleagues, academic administrative staff, and other relevant bodies
  • Attend research meetings, seminars, and other relevant educational activities
  • Make full use of the training facilities on offer through King’s College London Staff Training & Development Unit – the College is committed to the training and development of its staff.

Decision Making, Planning and Problem Solving:

  • Contribute to decisions in carrying out this trial to ensure that it runs to timetable and the study protocol.
  • The post holder will be expected to consult on major decisions with Professor Gail Gilchrist.

Special requirements:

  • You will be required to travel to probation sites in London and may be required to attend research team meetings at most bi-annually in Manchester, Edinburgh and Cardiff.
  • You will need to be able to build a rapport with the participants in the study.
  • Information of a confidential nature must be kept strictly confidential and should never be disclosed either inside or outside work. It should be noted that breach of confidentiality is a serious offence which may lead to dismissal.

Skills, knowledge and experience

Essential criteria

1.      A degree in a relevant area (e.g. psychology, health services research, criminology, sociology or related discipline)

2.      Postgraduate qualification or equivalent, which includes clinical trials methodology

3.      Training/ qualification in research or trial management

4.      Proven multi-centre trial and project management experience

5.      Demonstrated experience of clinical trial monitoring

6.      Evidence of successful preparation and maintenance of regulatory and ethics submissions, and study protocols and related materials

7.       Proven ability to prepare research papers, reports and conference presentations to a high standard

8.      Experience of working directly and achieving results with a wide range of stakeholders

9.      Excellent attention to detail

10.   Ability to work independently as well as part of a team

11.    Excellent communication skills both written and oral (including the ability to communicate with a range of different stakeholders, such as research participants, healthcare staff and managers)

12.   Effective project management skills, including the ability to organise work, conflicting priorities and time effectively to meet deadlines

13.   Working knowledge of and ability to adhere to the current UK Clinical Trials regulations, Principles of GCP, Data Protection Act and Research Governance Framework legislation

Desirable criteria

1.       Supervision of research staff

2.       Strong academic record

3.       Budget management experience

This post is subject to Disclosure and Barring Service and Occupational Health clearance.

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