Clinical Site Coordinator
Cambridge, Cambridgeshire, England
£0 per year
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.
- 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:
- Proven experience in clinical trial conduct at clinical trials sites
- 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, organised; ability to keep oversight and multi-task
- Ability to conduct clinical trial procedures accurately in order to deliver high quality data
- Eager to learn
- 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
- 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 research practitioner or equivalent through experience
- Previous experience working in clinical trials in hospital or academic sessions
- Good social skills
- Good eye for detail, accurate
- Good technical skills to carry out required assessments
Posted 43 days ago