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Essay Coordinator (part-time) at KINGS COLLEGE LONDON

job description

About Us :

King’s College London Cancer Prevention Group specializes in research to advance cancer prevention, early diagnosis and screening.

We research the effectiveness, cost-effectiveness and technologies to improve existing screening programs and establish new ones.

Our portfolio of secondary (hospital) and primary (community) care trials includes:

• Multicenter international randomized controlled trials of drug prevention of cancer often using drug redirection

• Pragmatic trials of screening and diagnostic interventions

• Trials of behavioral interventions in cancer prevention and screening

• Testing of diagnostic/screening devices

About the role:

We are looking for someone with clinical trial coordination experience to join the CPG team in a trial coordinator role to support and contribute to the management of an exciting multicenter study (the FIT study for Lynch) funded by the Curing Colon Cancer Charity.

The objective of the FIT for Lynch study is to explore the effectiveness of fecal immunochemical testing (FIT) as an additional surveillance modality in people with a pathogenic variant of Lynch syndrome (LS).

The faecal immunochemical test (FIT) is routinely used in the National Health System (NHS) bowel cancer screening program and has demonstrated clear additive value as an effective and efficient non-invasive mechanism for triaging patients via the baseline of two weeks of waiting (2ww). However, the use of this device remains to be observed as a surveillance intervention within the Lynch syndrome (LS) patient population.

The post holder will be based in the CPG team and will be supported by the Clinical Project Manager. They are expected to provide all aspects of day-to-day project coordination with particular emphasis on data collection and entry, central, remote and on-site monitoring and trial administrative duties. This is a part-time role due to the number of sites and the relatively simplistic design and requirements of the trial.

You will report to and be supervised by a clinical project manager within the CPG. You will need to develop strong working relationships with investigators, database developers, trial managers, statisticians and other trial/data coordinators both at King’s and external locations. We appreciate your professional growth and you will have the opportunity to attend conferences and training.

This is an excellent opportunity to gain experience in coordinating and monitoring trials in a multicenter cancer screening pilot study.

This position is currently a hybrid job in response to COVID-19. The job holder should be in the office at least 1 day per week. For this reason, the job holder must be self-motivated and able to work independently.

This position will be offered on a fixed-term contract until 31/05/2025

This is a part-time position equivalent to 50% full-time

Main responsibilities

• Work in multiple areas of trial operations including administration, REC and HRA requests and changes, data management, central/on-site monitoring and closure

• Assist with trial set-up activities including Site Initiation Visits (SIV)

• Assist in the preparation and/or updating of trial-related documentation, such as master trial and site investigator files, screening logs, progress reports ( for example, for regulatory and funding agencies and trial management group)

• Ensure the project complies with applicable regulatory requirements including Human Medicines (Clinical Trials) Regulations, Data Protection Act, Human Tissue Act 2004, UK policy framework for Health and Social Care Research and Health and Social Care (National Data Custodian) Act 2018

• Manage site monitoring visits to participating centers to verify study data and protocol compliance, as well as manage monthly central and remote monitoring of study data, looking for trends in recruitment or data with excellent attention to detail

• Communicate results of follow-up visits to local investigators and provide additional training as needed

• Supervise and manage the cleaning and validation of data received from sites and suppliers according to data management plans; follow up on missing datasets and reports, if any

• Distribution of confidential information, ie participant consents, etc.; to the respective sites

• Plan long-term monitoring logistics to support passive monitoring data collection using health registers*

• Organize, chair, attend and contribute to meetings as appropriate i.e. Trial Management Group meetings and other unit and trial level meetings

• Work with project teams to identify and manage risks to project success by monitoring quality assurance

• Work independently to achieve project reporting milestones

• Undertake administrative and other duties related to the project or GPC objectives as can reasonably be expected, as agreed with line manager

• Travel to England as required, liaise with key stakeholders, laboratories and research sites (pending COVID restrictions)

*Note that this depends on obtaining additional funds

The above list of responsibilities may not be exhaustive and the post holder will be required to undertake the duties and responsibilities reasonably expected within the scope and classification of the post.

Skills, knowledge and experience

Essential criteria

1. An undergraduate degree in any life science or equivalent professional qualification

2. Understanding of regulatory requirements relating to clinical trials, research, the Declaration of Helsinki and any other applicable regulations.

3. Experience working in multiple areas of trial operations including administration, REC and HRA applications/amendments, data management, tracking and closure.

4. Experience in liaising and supporting participating clinical research sites.

5. Previous experience overseeing the quality of data collected through research or an understanding of the key standards required for collecting and handling data in research

6. Demonstrated ability to work independently to achieve project milestones, using problem-solving skills to adopt a pragmatic and flexible approach while maintaining compliance with policies and regulations

7. Excellent numeracy and accuracy skills with a high level of attention to detail

8. Excellent written and verbal communication skills enabling effective communication with a range of clinical, academic and non-academic staff through a variety of media.

9. Willingness and ability to travel within England to hospitals to meet project needs

Desirable criteria

10. Experience conducting central, remote or on-site monitoring

11. Experience working on CTIMPs

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