Clinical Trials Administrator - Cambridge, United Kingdom - Owlstone Medical

Owlstone Medical

Verified Company

Cambridge, United Kingdom

2 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

Owlstone Medical Ltd is on a mission to save 100,000 and $1.5billion in healthcare costs through Breath Biopsy.

This unique, industry-leading technology analyses exhaled breath for biomarkers of disease, enabling crucial early detection and helping to stratify patients for precision medicine.

To achieve this, we design and conduct several projects to discover biomarkers associated with disease and we are now looking for a highly organised and self-motivated Clinical Trials Administrator (CTA) to join our clinical trials team.

To fulfil our mission to save lives, we conduct a range of clinical studies, including observational trials, first in human trials, proof of concept studies and later stage trials as required in order to support breath biomarker discovery, development and safety assessment of novel probes of metabolism and medical device development and approval.

This diversity means that every study has its own unique challenges to overcome.

The CTA will support the clinical trials team across a programme of internal and external studies from study start up to close down.

You will be expected to perform the following tasks for all clinical studies, under the guidance of a Clinical Trials Coordinator or Study Manager as required.

You will be responsible for the following:

Main Responsibilities:

Carry out breath sampling on site for internal studies
To provide general administrative support to the clinical trials team.
To setup, organise and maintain the Trial Master File, ensuring audit readiness.
To assist in the tracking of project progress and activities.

Study set up:

Assist with the preparation, handling and tracking of Ethics and Regulatory submissions, annual safety and end of trial reporting, and facilitating any correspondence.
Request equipment from Manufacturing for shipment to clinical sites and tracking samples. Assist with the preparation of laptops and endtoend testing.
Assist with the preparation of training documentation.
Assist with the preparation of the Site File

Study conduct:

Assist with Internal sampling activities (including recruitment, consent and obtaining breath samples)
Coordinate the study logistics with regards to ordering, provision and on time delivery of study equipment and consumables to maintain recruitment activities.
Keep accurate records of equipment and consumables at site.
Ensure sites return samples and unused consumables in a timely manner.
Complete quality curation checks on samples and request repeats where required.
Set up meetings and records minutes as required.
Keep accurate records of all decisions and site contacts.
Assist with recruitment tracking and data entry review
Ensure sites are sent copies of updated documents and approvals
Maintain the TMF throughout the life cycle of the study.
Raise and log nonconformances and contribute to CAPA investigations.
Contribute to updates and reviews of departmental SOPs.

Study Close Out

Liaise with sites and manufacturing with regards to the return of equipment at the end of a study
Taining and other study support as required.
Assist CTC in ensuring all documentation is complete and present in the TMF at the end of the study and archive as appropriate.
To work with the clinical team to ensure prompt resolution of data queries.
Assist with preparation of study documents and trackers

Requirements:

Essential

Further education in a technical or science discipline or equivalent
Previous experience working in an admin support role and/or an administrative support role in a clinical trial setting.
Excellent written and verbal communication skills
Good time management and organisational skills
Enthusiastic
Ability to use initiative.
Able to adapt to changing priorities.
Confident in using Microsoft Office.

Desirable

Experience in a similar CTA or administrative role
Knowledge of ICH GCP/FDA regulations and relevant UK Statutory Instruments and EU Directives
Experience of working within an ISO 9001 Quality Management System and/or clinical trials regulated environment.
Experience of Good Clinical Practice (GCP)

Benefits:

About Owlstone Medical

Our leadership in-breath is underpinned by our world-class and varied team, including systems engineers, clinical scientists, analytical chemists, artificial intelligence specialists and clinical trials coordinators.

The Owlstone group also commercializes 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 Defense.

We offer a relaxed, friendly, flexible and international working environment with a strong and vibrant team-spirit.

You will be rewarded with a competitive salary package that includes an Employee share options scheme and private medical insurance and your work will have a clear impact on people's lives.

If you want to experien