Location: Camberley/Frimley Business Park
Reference: MLJ CSS 4
Closing Date: 06 Feb 17
Type: Full Time
Salary (£): Negotiable
Benefits: 25 days leave increasing to 30 over time, potential to buy up to 40 days, pension, life insurance, health benefits, gym subscription contribution
Chiltern Source acts in a similar way to that of a staffing solutions provider. Chiltern Source supplies high quality and experienced clinical professionals to the pharmaceutical industry, we currently have over 400 staff working with our clients globally. The department is currently seeking a UK Clinical Trials SET UP. Chiltern Source acts in a similar way to that of a staffing solutions provider.
This is a full time office based role with a top ten pharma company based at junction 4 off the M3 in Frimley business park.
The role would suit candidates who are particularly interested in study start up activities in the UK and Republic of Ireland.
If you have awareness of the current regulations for ethics and R and D approvals this will be a major advantage in your application.
We particularly welcome applicants from within the NHS who have clinical trials start up expertise/governance and who are looking to make the move into commercial pharma operations.
You may have been a study site coordinator or research nurse perhaps.
To provide an efficient and professional ethics and R&D set up service within required timelines according to company SOPs and ICH GCP guidelines and to provide advice and knowledge to project managers and clinical associates regarding the ethics / regulatory processes in the UK and Republic of Ireland.
Accountable for rapid study set up for all clinical trials across UK Operations and ensures that they are provided with a first in class study set up service.
Works closely with Clinical Set Up and Logistics Manager to identify process improvements for a more efficient
service of ethics and trial set up.
Advises clinical project teams and department with regards to new processes and procedures concerning
ethics and R&D processes and advises Project Managers and field based CRAs on submission timelines.
Proof reads ethics submissions and documentation for Clinical Project Managers and liaises with Medical Advisers
Takes the lead on new Regulatory department processes and trains team appropriately.
Performs site monitoring activities such as unmasked monitoring and site drug supply management when required.
Collates, prepares and submits MREC and SSI applications to the earliest possible review meetings following
NRES and ICH GCP and collates, prepares and completes R&D applications for R&D submissions during trial
set up period.
Is responsible for contract / budget negotiations with R&D/PCTs for ICRO clinical trials
Responsible for clinical trial set up, facilitates preparation and collection of country and site level documentation
to ensure drug shipment without delay.
Is accountable for timely distribution of trial safety data for specified products as per regulatory requirements to
ethics and R&D departments and well as the submssion progress and end of study clinical reports to SOPs and NIPs and local authority requirements
Liaises with Global interfaces and other departments to ensure correct reporting documentation is received for submission
The role would suit candidates who are particularly interested in study start up activities in the UK and Republic of Ireland. If you have awareness of the current MHRA regulations for ethics submissions and R and D approvals this will be a major advantage in your application. We particularly welcome applicants from within the NHS who have clinical trials start up expertise in perhaps a governance role and who are looking to make the move into commercial pharma operations.You may have been a study site coordinator or clinical trials coordinator for example OR research nurse OR perhaps a CRA who is now looking for an office based role with minimal travel
Please call Marc Joseph on 01753 216664 for further detail and information or send your CV directly to email@example.com.
key words in house CRA, study start up, ethics, clinical trials administrator, CTA, monitoring, set-up specialist, clinical operations
171 Bath Road Slough Berkshire
SL1 4AA, UK
|Tel:||+44 (0) 1753 512000|
|Fax:||+44 (0) 1753 511116|
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