Location: Junction 4 off the M3
Closing Date: 03 Feb 17
Type: Full Time
Salary (£): 20,000 - 30,000
Benefits: PAYE employment with CHILTERN, 25 days leave, pension, LI 4 x salary, gym membership contribution
This role is ideal for a junior CTA or rookie in house CRA who wants to build their Clinical Operations career, or a junior clinical associate just starting out in industry. Ideally we need someone with at least 6 months clinical trials administration experience who has worked within operations on UK studies.
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 to a top ten pharmaceutical company.
The role is VERY BUSY and needs a great multi tasker and someone with excellent organisation skills. 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 Duties
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 Duties
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)
"This definitely needs to be someone who can really organize their work load, multi-task and be a good communicator - these are vital skills needed here."
Ideally you would have previous Pharma/CRO experience in a similar CTA role but as always not essential for the right person . So maybe YOU are currently in your first 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 -1 8 months
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 and discussion
key words clinical trials administrator, junior CRA, study support, start up, CTA, clinical support associate
171 Bath Road Slough Berkshire
SL1 4AA, UK
|Tel:||+44 (0) 1753 512000|
|Fax:||+44 (0) 1753 511116|
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