Location: Frimley Business Park, Surrey, UK
Closing Date: 02 Jan 17
Salary (£): Negotiable
This role sits within the UK Clinical Trial Start Up and Logistics group within a top pharma company.
This vacancy offers permanent PAYE employment with Chiltern Source - part of the larger Chiltern CRO.
Your initial project would be a 12 month rolling secondment/contract to our Client, a top ten global pharmaceutical company based in Surrey/Hampshire borders.
You would have a full time permament position with Chiltern but would work 100% full time office based just off junction 4 of the M3 in our Client's UK office.
Accountable for rapid study set up for all clinical trials across UK and Ireland and ensures that the group 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 concern-ing 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 Ad-visers when needed.
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 re-quired.
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 clinical trials
Responsible for clinical trial set up, facilitates preparation and collection of country and site level documenta-tion 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
Please call Marc Joseph on 01753 216664 for further detail and information.
Key words, CTA, clinical trials administrator, clincal document administrator, IRAS, start up
171 Bath Road Slough Berkshire
SL1 4AA, UK
|Tel:||+44 (0) 1753 512000|
|Fax:||+44 (0) 1753 511116|
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