Job Opportunities

Job Opportunities

We currently have one job opportunity for a Clinical Trials Coordinator:

Clinical Trials Coordinator - Full Time

DynamX Medical trading name of BeamLine Diagnostics Ltd. was founded in 2015 by Dr. Liberty Foreman and Dr. Katherine Willetts based on PhD research. DynamX is developing a point-of-care system that will streamline the cancer diagnostic pathway.

Over three years DynamX has grown in to a leading start-up med-tech company, running our own clinical trials across the UK. We have now reached a stage where we would benefit from someone coordinating our clinical trials, the clinical development of them and improving the design of our user interface full time.

Our main focus is on cancer or life-threatening disease screening. Our most advanced study is in the gastrointestinal tract in which we have recently completed a 400-patient cancer screening clinical study across four sites in England. We are in the process of setting up a larger follow on study with the possibility of setting up a site in Los Angeles and includes a stronger focus on histopathology utilising a centralised lab. Other trials include a 450-patient study for early lung cancer screening at the Queen Alexandra Hospital, Portsmouth and we are actively looking to expand our disease portfolio.

This is an exciting opportunity for someone looking to work with an innovative and dynamic scientific start-up. You will report directly to the CEO and will have exposure to varied aspects of science and product development. The successful applicant will be directly involved in bringing cancer screening tools to market. There is the opportunity to progress to clinical trials manager and being solely responsible for all clinical trials conducted. 

 

Job description

DynamX Medical’s screening tools are pre-approval, we are currently running and setting up observational clinical studies to gather data that will form part of a CE/FDA submission.

You will be responsible for setting up, coordinating and managing the multi-centre studies and ensuring data quality at sites. As part of this role relationship management of hospital staff is vital as we intend to transition these sites into early adopters of our future commercialised product. As this role develops, you will play a key part in the CE/FDA submission of our products.

The role is predominantly office-based but will require travel within the UK (and possibly overseas) to visit sites and attend meetings and conferences, as necessary. It is essential that the successful applicant is flexible about the amount of travel required as this may vary over time.

Responsibilities:

  • Perform site feasibility selection, initiation, monitoring and close-out visits in accordance with contracted scope of works and good clinical practice
  • Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
  • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
  • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
  • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrolment, case report form completion and submission, and data query generation and resolution.
  • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow up letters and other required study documentation.
  • Establish and maintain the Trial Master File.
  • Assist with eCRF development.
  • Remotely monitor data progress at sites, observing workflows at each site to optimise data collection and help inform product development strategies.
  • Gather and record feedback from Research Nurses and other product users to aid DynamX’s product development from a user perspective.
  • To identify and maintain familiarity with all current legislation and guidelines relevant to monitoring and oversite in clinical trials.

Career Development:

  • Full exposure of the full clinical trial lifecycle, from study concept to publication.
  • Working in a small company the individual will have the opportunity to gain extensive experience and scope future product development.
  • Progressing to Management as further clinical trials are planned.

 

Individual Requirements

Essential:

  • Experience of writing trial reports, and ability to write in unambiguous and clear language.
  • Ability to assimilate information from many sources and compile into workable documents.
  • Time management and problem-solving skills, with the ability to manage multiple projects, work to deadlines and prioritise work effectively.
  • Excellent attention to detail and accuracy.
  • Ability to use initiative, checking with line manager appropriately.
  • Flexibility and willingness to travel as required, as the post will require some travel to sites and external meetings.
  • Computer literate.

Desirable:

  • Experience in clinical trials including experience of monitoring trial sites in the NHS.
  • Experience of trial management.
  • Experience of staff training.
  • Experience with audit and/or statutory inspections.
  • Understanding of relevant current clinical trial and research regulations (In particular the EU Clinical Trials and GCP Directives, the Medicines for Human Use (Clinical Trials) Regulations and Research Governance Framework).
  • Familiarity with SOPs, SOP writing and document version control.
  • Knowledge of cancer and cancer therapies.

We Offer:

  • A competitive salary (£32k - £40k), plus car allowance
  • Career development.
  • Fixed office space at Rutherford Appleton Laboratories.

Please Provide:

  • A short cover letter.
  • A current CV.

Assessment:

Assessment will normally be in two stages

  • A phone screening.
  • A face-to-face interview.

© 2019 DynamX Medical is the trading name of BeamLine Diagnostics Ltd.
Registered in England & Wales Number 09504725.
Rutherford Appleton Laboratories, Atlas Building R27 Office F28, Harwell Campus, Didcot, OX11 0QX
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