Clinical Trials Administrator - NHS Galleri Trial

Job description

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 enthusiastic clinical trials administrator to join the CPTU team to contribute to the coordination and operational delivery for a ground-breaking cancer screening study. 

 

A clinical trial administrator will be recruited to support the administration and coordination of the NHS-Galleri multi-cancer early detection project.  Over 1,000,000 people across England have been invited to receive a novel CE-marked, blood test for the presence of over 50 cancers. The study aims to recruit 140,000 participants and the recruitment period is due to close in the Summer of 2022. Participants that have enrolled into the trial will be followed up on a yearly basis for a further two years. You will support a broad range of trial coordination and administration activities to successfully underpin the project. 

 

You will have a strong interest in clinical trials research, and experience of working in a similar role. You will have excellent organisational, planning, interpersonal and IT skills.  You will be adept at working flexibly and be able to work effectively as part of a team or independently. You will ideally have knowledge of clinical trial regulations, GCP and research governance standards. 

 

The administrator post will collectively with work within the CTA team to provide operational support across the project.  Tasks will be delegated and will include: 

 

• Keeping the electronic TMF up to date in response to changes in the protocol or regulations and ensure that the study is run in compliance with the protocol, ICH GCP and all applicable regulations.  

• Acting as first point of contact for the trial vendors and data providers, GP practice staff, participants and the study sponsor, responding efficiently and politely to telephone and email enquiries, seeking advice or forwarding them to other members of the study team.  

• Providing regular feedback to the trial team about the progress of invitations, recruitment and enrolment.  

• Supporting the continued management of recruiting sites and ensure their trial documentation is up to date. 

 • Supporting the general administrative tasks associated with running a busy research project including organising and minuting team meetings. 

 

You will report to and be supervised by the Trial Manager or Project Manager.  

 

This post will be offered on an a fixed-term contract for 2 years 9 months 

This is a full-time  post - 100% full time equivalent

 

Key responsibilities

                    

• To support the Trial Manager, Project Manager and Clinical Project Manager in the day to day management of the trial. 
• Act as a point of communication for the trial for the research team, recruiting sites and all other relevant bodies including NHS DigiTrials and vendors associated with the project.  
• Assist the Trial Manager in the development, implementation and update of the electronic Trial Master File and version control of relevant study documents. 
• Develop a good knowledge of the trial protocol, to be able to respond to all queries or appropriately escalate. 
• Monitor and coordinate intervention supplies and intervention compliance under the direction of the Trial Manager. 
• Assist the Trial Manager with the planning and monitoring of trial recruitment, as appropriate. 
• Ensure Site Initiation Visits are arranged, and compilation of Investigator Site Files, vendor files and trial specific equipment is provided in a timely manner to prevent delay with a site recruiting. 
• Assist in the coordination of Trial Management Group meetings, Trial Steering Committee meetings and Data Monitoring Committee, study specific training days, preparing agendas and minutes and all other arrangements required. 
•  Work with the Trial Manager and the Chief Investigator on a daily basis to ensure the project progresses well, providing updates on site set up or other activities as needed during trial meetings. 
• Distribute mailshots, newsletters and publications as directed by the Trial Manager.   
• Contribute to collaborative decision-making, planning and short and long-term objective setting. 
• Use initiative and creativity to resolve issues that might arise and identify issues that require onward reporting in liaison with the Trial Manager.  
• Assist in the creation of trial progress reports as required. 
• Collate and disseminate reported SAEs for review as requested by the Trial Manager, checking for missing or inconsistent data and querying sites, ensuring all events are followed up to resolution.  
• Assist in the cleaning and preparation of data for visit reporting and analysis of study targets. 
• Assist with testing of the trial database system for data entry and randomisation system for randomising participants. Onward report to the Trial Manager any missing, contradictory or incorrect data so that these problems are followed through to a satisfactory conclusion within a reasonable timescale.  
• Assist the Project Manager with participant appointment logistics, including maintaining oversight of activities relating to the participant call centre, and monitoring web bookings. 
• Acting as first point of contact for the trial vendors and data providers, GP practice staff, participants and the study sponsor, responding efficiently and politely to telephone and email enquiries, seeking advice or forwarding them to other members of the study team to answer, as appropriate. 
• Support the trial team to ensure appropriate archiving of all ‘essential documents’. 
• Ensure confidentiality on all matters and information obtained during the course of employment. 
• Any other duties appropriate to the grade as directed by the supervisors.  

 

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 

Essential Criteria:

1.      Degree in any life science or numerate discipline, or a professional qualification (e.g. nurse) or relevant experience in a similar role  

2.      Experience of working in research or clinical trials studies in a similar role

3.      An understanding of ICH/GCP guidelines  

4.      Excellent IT skills including working with databases and electronic data capture systems  

5.      Ability to work on own initiative and prioritise own schedule with little supervision  

6.      Excellent organisational skills

7.      Methodical and accurate in the gathering and recording of data with excellent record keeping ability  

8.      Excellent verbal and written communication skills

9.      Flexible and positive attitude with an interest in clinical research

 

Desirable:

1.      Understanding of regulatory requirements pertaining to trials  

2.      Experience of meeting administration and organisation’ Experience of working within a clinical trials unit/pharmaceutical industry  

3.      Experience of working with a clinical trials vendor/service provider

4.      • Experience of working on trials that utilising data providers e.g. NHS Digital, NCRAS etc.  

 

Further information

This post involves a hybrid model of home working and office base