Location: Junction 4 off the M3 (Frimley)
Reference: MLJ CSA3
Closing Date: 02 Jan 17
Salary (£): 20,000 - 30,000
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.
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.
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)
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
171 Bath Road Slough Berkshire
SL1 4AA, UK
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