Clinical Site Coordinator

Cambridge, UK

Job Purpose:

The Clinical Site Coordinator supports the Principal Investigators and site staff in the day-to-day performance of Owlstone Medical sponsored clinical trials. As Clinical Site Coordinator you will work independent from Owlstone Medical’s clinical trials department; you will be primarily based at the Clinical Research Facility at Addenbrooke’s Hospital (Cambridge), although from time to time you may be required to provide support to other clinical sites participating in one of Owlstone Medical’s clinical studies and/or assist in breath sample collection at Owlstone Medical. You will support the sites mainly by performing accurate breath collections and performing data entry in the eCRFs for the clinical trial(s) as well as ensuring that the study is carried out to the highest standard.

Key Tasks/Responsibilities:

Study set up:

  • Assist the local Principal Investigator and designated site staff with the set-up of the study at the clinical site (applying for local and/or ethic approvals as needed, review study documentation, determine most feasible way to recruit subjects and carry out the protocol requirements, …)
  • Closely report study set-up progress as well as potential issues to the Principal Investigator(s) as well as to the responsible Clinical Trials Coordinator and/or the Project Manager Clinical Trials at Owlstone Medical.

On-site Trial Coordination:

  • Collaborate with the multidisciplinary team on site (Principal Investigator and/or designee, nurses, …) to run the clinical trial(s) in the most efficient way, adhering to the local and regulatory guidelines
  • Collaborate with the multidisciplinary team on site (Principal Investigator and/or designee, nurses, …) to identify eligible patients for the study.
  • If required and delegated by the Principal Investigator , obtain consent from potential study subjects
  • Collect high quality breath samples in accordance with the instructions for use of Owlstone Medical’s breathalyzer
  • Ensure appropriate and timely shipment of the collected breath samples to Owlstone Medical’s Clinical Lab and maintain the required documentation
  • Collect clinical data required per protocol during screening, breath collection and follow-up.
  • As and when needed, perform other clinical procedures if required per protocol (venepuncture, blood pressure, …)
  • Maintain Investigator Site File
  • Serves as primary liaison between the clinical research sites and Owlstone Medical’s in-house Clinical Trials Coordinator
  • Serves as primary point of contact on-site for the independent clinical monitor during and in-between independent monitoring visits.

Data Entry:

  • Assist the Principal Investigator and other designated site staff members with accurate and complete data entry ( in line with study specific eCRF completion guidelines ) in a timely matter and aiming to minimise the number of data queries to be raised by independent Clinical Data Manager and/or clinical monitor(s).
  • (support the local study team and/or PI) in address(ing) in a timely and accurate manner data queries raised by Owlstone Medical Clinical Data Manager and/or independent clinical monitor(s).
     

COMPETENCIES & REQUIREMENTS OF THE ROLE:

Essential:

  • Excellent communication and reporting skills
  • Good social skills, good interaction with patients and site staff
  • Ability to work independently as well as demonstrating team player mentality
  • Detail orientated
  • Ability to conduct clinical trial procedures accurately in order to deliver high quality data
  • Eager to learn
  • Organised; ability to keep oversight and multi-task
  • Flexibility to work on different studies, with different departments
  • Willing to travel (within UK and primarily Cambridgeshire)
  • Good knowledge of ICH-GCP and/or ISO 14155

Desirable:

  • Previous experience working in clinical trials at clinical research sites
  • Ability to perform clinical assessments such as venepuncture, monitor heart rate and blood pressure, ECG, …
     

Person Specification:

Education & Training:

  • Qualified (research) nurse or equivalent through experience
     

Experience/Knowledge:

  • Previous experience working in clinical trials in hospital or academic sessions

Skills:

  • Good social skills
  • Good eye for detail, accurate 
  • Good technical skills to carry out required assessments

About Owlstone:

Owlstone Medical has developed a breathalyzer for disease www.owlstonemedical.com.

Every time you breathe out there are hundreds of chemicals on your breath - some are tell-tale markers of disease that our microchip chemical sensor technology is able to detect.

Our vision is to change the way we currently diagnose and monitor serious disease; we aim to become the global leader in the non-invasive detection of cancer, infectious disease and inflammatory disease. The key is detecting diseases earlier, when treatments are more effective, where more lives can be saved. There is no better example than cancer, where if detected early the chances of survival can be as good at 95% but at late stage drop to about 5% - unfortunately there are still far too many people detected at late stage.

The Owlstone group also commercialises a range of highly innovative products based on its proprietary FAIMS chemical sensing technology in other markets including Scientific, Industrial Process Control, Military and Homeland Defence.

Owlstone is an equal opportunity employer and we will consider all qualified applicants for employment without discrimination on any characteristic protected by law including but not exhaustive to; grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status.

Due to the nature of our business, all employment is subject to satisfactory references being obtained and attainment of a Baseline Personnel Security Standard (BPSS) check.

We offer a relaxed, friendly, flexible and international working environment with a great team-spirit. You will be rewarded with a competitive salary package that includes future share options and your work will have a clear impact on people’s lives. If you want to experience the buzz of an expanding company set to succeed on a global scale, Owlstone may be the place for you.

To apply, please submit your CV and a covering letter explaining why you want to work with us by clicking on the link below.  

https://app.smartsheet.com/b/form/02cae1ac57a34f588daeccae5c1e7ee7

 

 

 

 

 


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