We are seeking an enthusiastic individual with a keen interest in the management of clinical trials and ideally with previous experience of working in a research environment. The successful candidate will work within the accredited UKCRC King’s Clinical Trials Unit (KCTU), providing administrative support to large multi-centre clinical trials. In addition to working with senior trial managers and other colleagues in KCTU, the post holder will work closely with the trial’s Chief Investigator and the KCTU’s Operational Director, to ensure rigorous trial standards are maintained
Duties will include:
- 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.
- 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, staff are appropriately trained, and recruitment is maximised at the study 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
- manage the Trial Master File and version control all trial documents
- be a key liaison with all university departments, relevant ethics and R&D committees, funding bodies etc
This post will be offered on a a fixed-term contract for 30 months
This is a full-time post - 100% full time equivalent but we also encourage part time applicants to apply as there may be more than one post available.
- Responsible for the day-to-day management of the trial
- Act as the main point of communication for the trial, the research team, recruiting site and all other relevant bodies.
- Develop, implement and update the Trial Master File and version control relevant study documents
- Develop an in-depth knowledge of the trial protocol, to be able to respond to all queries or appropriately escalate
- Monitor and coordinate intervention supplies and intervention compliance (supported by the KCTU pharmacist)
- Plan and monitor recruitment of participants into the trial, identifying barriers and implementing strategies to improve recruitment.
- Initiate the sites, ensuring they have the required documentation, appropriate approvals and an understanding of the protocol.
- In conjunction with the trial statistician, monitor data quality and assist with data cleaning, to achieve an accurate and complete dataset.
- Schedule and administer Trial Management Group meetings, Trial Steering Committee meetings and Data Monitoring Committee meetings and take minutes as appropriate
- Prepare and submit amendments for ethics and regulatory approval, annual progress reports, contribute to reports to funders and manage communications with the Sponsor organisation. Ensure appropriate contractual arrangements are in place and documents held on file.
- Plan and monitor financial aspects of the trial, including forecasting major expenses and identifying underspend or overspend.
- Produce promotional material and dissemination plans.
- Develop written procedures for trial processes where appropriate
- Any other duties appropriate to the grade as directed by the supervisors.
Skills, knowledge, and experience
- Degree qualification in a science subject or relevant professional qualification
- Proven commitment to ongoing skills development
- Excellent IT skills including working with databases
- Excellent organisational skills with an ability to predict, identify and resolve problems that are critical to the running of the trial and plan strategically to avoid them
- Ability to work on own initiative and prioritise own schedule without supervision
- Experience of working in research or clinical trials, with an understanding of GCP guidelines
- Experience of using complex databases and management information systems
- Excellent verbal and written communication skills, particularly in the context of scientific writing, reports, presentations and telephone manner.
- Willing to travel with the UK flexibly to accommodate the needs of the project
- Ability to show attention to detail and high standards of accuracy in all aspects of work, with a flexible, enthusiastic, team-working attitude
- Understanding of medical terminology, either through study or working in a medical environment
- Knowledge of project management methodology and commitment to acquire complete project management skills
- Post graduate qualification with a research methodology element
- Experience of financial planning and implementation