Clinical Trials Administrator
3 days left
- Full Time
The Cancer Research UK & King’s College London Cancer Prevention Trials Unit (CPTU) specialises in research to advance cancer prevention, early diagnosis and screening.
We perform research on efficacy, cost-effectiveness and technologies to improve existing and establish new screening programmes.
Our portfolio of both secondary (hospital) and primary (community) care trials includes:
• Multi-centre international randomised controlled trials of medicinal prevention of cancer often using drug re-purposing
• Pragmatic trials of screening and diagnostic interventions
• Trials of behavioural interventions in cancer prevention and screening
• Trials of diagnostic/screening devices
About the role:
We are looking for an enthusiastic clinical trials administrator to join the CPTU team, to support the coordination and operational delivery of two new research projects funded by Yorkshire Cancer Research.
FINESSE (FINasteride Evaluation in Surveillance for proStatE cancer) is a CTIMP in secondary care, investigating whether finasteride can be used to improve active surveillance by reducing the number of men who undergo surgery or radiotherapy needlessly. YORKSURe (Yorksure Screening of URine trial), is investigating home urine testing for bladder cancer, in 3 separate cohorts spanning an existing screening trial population, primary care and secondary care.
The post holder will join the existing team (Clinical Project Manager, Trial Managers and Trial Coordinator) to support a broad range of administration activities for these two exciting projects that will open to recruitment in early 2022. You will report to and be supervised by the FINESSE Trial Manager.
You will be a skilled administrator with an interest in clinical trials/clinical research, preferably with experience of working in a similar/related role, from the NHS, academia, or industry. You will have excellent organisation, planning, interpersonal and IT skills, be adept at working flexibly and be able to work effectively as part of a team or independently. The post is currently hybrid working meaning your time will be split between working in the office and working remotely. Therefore, you must be self-motivated. You will ideally have awareness or knowledge of clinical trial regulations, GCP and research governance standards, and an interest in cancer prevention and screening.
This is a great opportunity for an experienced administrator looking for a varied and interesting role in clinical trials.
This post will be offered on an a fixed-term contract until 31st Jan 2024
This is a full-time post - 100% full time equivalent
- Develop a good knowledge of the trial protocols
- Assist in the coordination of internal and external trial meetings by preparing agendas, taking minutes, circulating papers and all other meeting arrangements as required.
- Assist in keeping the electronic and paper Trial Master Files (TMF) up to date, ensuring key documents are filed appropriately, and adhere to version control requirements.
- Liaise with participating trial sites under the direction of the Trial Managers, to cover a range of duties including distributing relevant study documents, Investigator, Pharmacy and Vendor Site Files, booking Site Initiation, Monitoring or Close-out visits, and requesting and chasing responses to site setup, monitoring or closure activities.
- Assist the Trial Managers/Trial Coordinator with acting as a first point of contact for the trials by efficient management of the trial mailboxes, ensuring that email enquiries are responded to politely and in a timely fashion, or escalated to the appropriate member of the team for response.
- Support the Trial Managers/Trial Coordinator with participant appointment provision to ensure all trial participants are able to attend follow up where required by the trial.
- Assist the Trial Coordinator/Trial Managers with data management activities for both projects.
- Assist the Trial Managers/Trial Coordinator with the preparation of mailshots, newsletters, trial progress reports and publications, including using IT skills to creatively design and generate documents for different audiences
- Provide support for the monitoring and coordination of trial supplies (including home urine testing kits) under the direction of the Trial Managers. Keeping records up to date and ensuring good communication with trial sites and vendors/suppliers to maintain timely deliveries where appropriate.
- Support the Trial Managers/Trial Coordinator with safety reporting for the trials, whilst ensuring adherence to trials specific and regulatory procedures, and reporting timelines.
- Contribute to the efficient and effective delivery of both projects, including tracking progress against milestones, reporting progress/feedback and taking part in collaborative decision making, planning short, medium and long-term goals with the trial team and Chief Investigator.
- Ensuring confidentiality on all matters and information obtained during the course of employment
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.
Skills, knowledge, and experience
1. Degree in any life science or numerate discipline, or a professional qualification as equivalent, (e.g. nurse) or relevant experience in a similar role
2. Experience of working as an administrator including meeting organisation and execution.
3. Excellent MS Office skills including working with databases and electronic data capture systems
4. Self-motivated, with an ability to work autonomously
5. Excellent organisational skills
6. Excellent verbal and written communication skills enabling effective communication with a range of staff
7. Methodological and accurate in the gathering and recording of data
1. Experience of working within a clinical trials unit or a similar/related role, from the NHS, academia, or industry.
2. Understanding of regulatory requirements pertaining to clinical trials.
3. An interest in cancer prevention & screening.