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Job Details

Clinical Support Associate (Study Start Up and Logistics)

Company: Chiltern
Location: Junction 4 off the M3 (Frimley)
Reference: MLJ CSA3
Closing Date: 02 Jan 17
Type: Contract
Salary (£): 20,000 - 30,000
Benefits:

Job Summary:

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 clinical support associate for a top ten pharmaceutical company. The CSA role is equivalent to a junior CTA level position.

Requirements:

This role is ideal for a CTA who wants to build their Clinical Operations career particularly in study start up, or a junior clinical trials associate just starting out in industry, although as stated above we would prefer someone with 6 to 12 months operations experience already on this occasion. This is an office based position just off junction 4 of the M3 in Surrey/Hampshire Borders. YOU would be employed permanently by CHILTERN on PAYE and seconded/contracted to a top ten pharmaceutical company on a rolling 12 months contract.

JOB DETAILS

The successful candidate will provide a central, key support function across multi-functional teams; including UK Operations and General Medicines Project Managers in the management of clinical trials within the UK.
 

Clinical Support Associate

Supports Clinical Project Teams to ensure good quality output for in-house clinical functions within the UK Operations Group.
 Works closely with In-House Set Up Team and Project Manages to improve rapid study start up and reduce study start up timelines
 Proactively assists Project Managers in running of clinical studies and supports field based CRA teams to max-imise study performance
 Has a good knowledge of ethics / R&D processes to ensure owned studies are on track
 Key, pivitol member of the clinical team to ensure support and communication between project teams
 Central point of contact for study related issues across medical and other departments within UK CPO
 Ensures all Safety Information for specified trials are distributed to investigational sites according to SOPs and prevailing law
 Peforms site visits when requested to assist with monitoring activities in the field, unblinded moniitoring and drug accountability to improve productivity within the department
 Is responsible for ensuring that Investigator payments are made on time and are accurately processed and has an excelllent knowledge of finance systems.
 Ensures all trial documentation is created, distributed, maintained and tracked, using electronic storage facili-ties (e.g. CREDI) where necessary, in accordance with SOPs and WPs in order to ensure smooth and timely running of trials
 Ensures that essential trial documentation is filed, CREDIed and upkept to regulatory requirements
 Responible for end of trial site file and TMF reviews when requested
 Is responible for the production of study aids and clinical documentation / manuals, e.g. Patient ID Cards, Diary Cards, Patient Information Sheets/Consent Forms for specified trials to a high quality standard
 Professionally sets up project tracking tools and ensures they are used efficently within the team
 Assists Clinical Project Managers in the organisation of investigator meetings when necessary
 Ensures essential databases (e.g. IMPACT and ACT) are maintained for specified trials
 

Senior Clinical Support Associate

 Mentors and advises Junior Clinical Support Team to ensure good quality output for in-house clinical functions within UK operations and to facilitate the achievement of CSA objectives set by Support Lead and Clinical Set Up and Logistics Manager
 Works closely with Support Lead to identify and develop Project Support Team’s needs to build skills and capabilities
 Takes the lead on new department processes and trains team appropriately
 Works closely with Line Manager to establish areas for developmental improvement within Logistic Team
 Provides a proactive, senior level of clinical support to Project Managers in running of clinical studies and supports field based CRA teams to maximise study performance
 Has exellent knowledge of investigator clinical trial payment systems and ensures that project teams are up-dated on a regular basis
 Proactively encourages new and Junior members of department in process improvement and new technolo-gies and coaches Junior Support Staff to ensure tracking databases (e.g. ISIS and Noah) are maintained and up to date
 Super user and system owner for Global tools eg ACT (responsibility of Project Manager but delegated to Senior CSA)

Further Detail:-

As my Client currently has quite a “young” team the candidate would have previous Pharma/CRO experience in a similar CTA role. So maybe YOU are currently in your first or second CTA role and are looking to build on your experience and be more of a career CTA as opposed to wanting to be CRA in the near future, (we would expect YOU to be happy in the CSA role for at least the next 12 -18 months).  This definitely needs to be someone who can really organize their workload, multi-task and be a good communicator and have had previous experience in a busy office environment, I think people always underestimate how much these vital skills are needed here!

Clinical Support Associate

Desired experience within the Pharmaceutical Industry / CRO enviroment with a good knowledge of Clinical Research processes in-cluding ICH GCP
 Excellent communication skills and an ability to multi task
 PC Literate - Intermediate Word, Excel, Powerpoint, Lotus Notes
 

Senior Clinical Support Associate

Previous experience as a Clinical Support Associate or CTA within the Pharmaceutical Industry / CRO enviroment with a good knowledge of Clinical Research processes including ICH GCP

In both roles, there is scope for medium to long term career development opportunities within the group.

Please contact Marc Joseph on 01753 216664 for further detail or send CV directly to Marc.Joseph@chiltern.com

key words clinical trial administrator, clinical support associate, junior CRA, junior clinical research associate, in house CRA, document specialist, document management, document manager, study start up, CTA


 

Apply for this job: Clinical Support Associate (Study Start Up and Logistics)

Contact Information:

Address:  London, UK
171 Bath Road Slough Berkshire
SL1 4AA, UK
England
Tel:  +44 (0) 1753 512000
Fax:  +44 (0) 1753 511116
Website:  Visit Our Web Site

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