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

We are looking for an enthusiastic trial manager to join the CPTU team to manage trial related activities for an exciting new early detection study in 2021.

Supporting the clinical project manager, you will be responsible for coordinating a small primary care sub-study within a larger NHS research study of a multi-cancer early detection test with GRAIL Bio UK Ltd, NHS England and NHS Improvement.  Over 700,000 people across England will be invited to receive a novel CE-marked, blood test for the presence of over 50 cancers. You will support the set-up and delivery of the sub-study in close coordination with GRAIL Bio UK and key stakeholders.

You will have a strong interest and knowledge of clinical trials research, and experience of delivering research projects in primary care. You will have excellent organisational and planning skills with an intrinsic interest in improving the health and well-being of communities through translational research and evidence-based innovation.
 
You will:

• be responsible for the sub-study set-up and coordination across  GP primary care sites, in particular related to protocol and GCP compliance and data collections
• Facilitate the execution of PIC standard agreements between the Sponsor and the trial sites
• Provide importable participants’ searches via data management expert or support GPs with building their own searches 
• Coordinate protocol and GCP training of the staff at the research sites
• With clinical input from the trial’s clinical research nursing team, oversee participant communications, scheduling and follow-up
• Analyse and review performance targets, and other deliverables and take relevant action to achieve study milestones
• Provide adhoc project management support to the Clinical Project Manager
• Be responsible for close down and archiving activities
• You will report to and be supervised by the Clinical Project Manager at CPTU.  You will  be required to develop strong working relationships with other trial managers across King’s. 

 
We value your professional growth and you will have opportunities to attend conferences and training. 
 
This post is currently home-working in response to COVID-19. For this reason, the postholder must be self-motivated and be able to work independently.
 
Hours:
Full-time 35 hours per week
Contract:
12-months fixed-term
 

Key responsibilities

• Responsible for the day-to-day management of the sub-study which includes: 
• Act as the main point of communication for the trial for the research team, recruiting trial sites
• Identify, recruit and support the participating trial sites, along with other site staff working in close collaboration with the local clinical research network staff e.g. SE London CRN.
• Support GP staff to perform searches for participants based on NHS digital SNOMED CT codes for inclusion and exclusion
• Oversee mailout and appointment activities
• Develop, implement and update the e-Trial Master File and coordinate the distribution of investigator files and version control relevant study documents
• Update the trial protocol, to be able to respond to all queries or appropriately escalate
• Plan and monitor recruitment of participants into the trial, identifying barriers and implementing strategies to improve recruitment
• Initiate sites, ensuring all have the required documentation, appropriate approvals and an understanding of the protocol
• 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
• Develop written procedures for trial processes where appropriate
• Work, where applicable, with the Sponsor, Chief Investigator(s), grant co-applicants, cancer Alliances, data managers, monitors, clinicians, statisticians and external agencies on a daily basis to ensure the project milestones are met
• Train and supervise other staff (internal and external) involved in data collection and data entry in the rules and procedures to be used, explaining the reasons/ principles behind them
• Communicate the underlying medical and scientific rationale of the trial to a wide professional audience, to ensure participant recruitment meets targets
• Plan and organise mailshots, newsletters and publications 
• Responsible for the completion, management and development of all relevant procedures for the conduct of the protocol
• Use initiative and creativity to resolve issues that might arise and identify issues that require onward reporting to the Chief Investigator and Sponsor
• Ensure that the trial protocol is conducted in accordance with the applicable ethical, regulatory and quality standards and that appropriate records and audit trails are maintained
• Prepare trial progress reports as required
• Monitor progress at each centre and take appropriate action to ensure milestones are met
• Monitor trial sites to problem solve and review source data where appropriate
• Set-up processes for monitoring trial supplies and arranging distribution to sites, designing documents to capture accountability data
• Work closely with sites to ensure timely data entry, cleaning and query resolution
• Ensure confidentiality on all matters and information obtained during the course of employment

Skills, knowledge, and experience 
 
Essential criteria: 
 

1. Degree in any life science or numerate discipline, or a professional qualification (e.g. nurse)
2. An understanding of ICH/GCP guidelines and other applicable regulations, including the regulations governing the research use of in vitro diagnostics
3. Excellent IT skills including working with complex databases and management information systems
4. Experience of managing a clinical research project ideally in primary care research or utilising GP PIC sites
5. Knowledge of project management methodology and commitment to acquire complete project management skills i.e. large-scale health or public sector-related projects with defined targets and performance milestones
6. The ability to predict, identify and resolve problems that are critical to the running of the trial and plan strategically to avoid them
7. Ability to work on own initiative and prioritise own schedule without supervision
8. Excellent verbal and written communication skills, particularly in the context of scientific writing, reports and good telephone manner. Ability to persuade and deliver information effectively through presentations
9. Willing to travel with the UK flexibly to accommodate the needs of the project
10. Ability to show attention to detail and high standards of accuracy in all aspects of work

 
Desirable criteria:
 

1. Formal qualification in clinical trials (or working towards one) and/or post graduate qualification with a research methodology element
2. Proven experience of all stages of a clinical trial from start up to close-out
3. Understanding of primary care electronic medical records systems e.g. EMIS and coding e.g. SNOMED CT

 
Further information
 
This post is based at Guy’s Hospital, London Bridge and GRAIL’s office in central London but will be remote working until further notice.  
This post is subject to Disclosure and Barring Service and Occupational Health clearance.