CSA(clinical support associate) - CTA Level Role

Recruiter
Chiltern
Location
Berkshire
Posted
23 Jan 2018
Closes
18 Feb 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Job Background We are currently seeking a UK based Clinical Trials Administrator (clinical support associate) You would be employed by Chiltern Source on a permanent PAYE salary and benefits, and seconded out to a top ten pharma company on a rolling yearly contract. This is an office Based Role in a fast paced dynamic environment focusing on UK and Ireland Study Start Up Actual job title is clinical support associate The Company officially certified by the Top Employers Institute for its exceptional employee offerings for the fourth consecutive year, and for the first time, Top European Employer Wide Therapy Area within General Medicine and Oncology Competitive salary and benefits Full support and a focus on development Free access to training Great team of people Would suit a career CTA or a junior CTA looking to develop within UK Clinical Operations, particularly in a study start up environment. We will consider 4 days/week or full time Permanent employment with Chiltern - seconded to a top ten pharmaceutical company 12 Months rolling contract PAYE salary and a wide range of company benefits 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 maximise study performance Has a good knowledge of ethics / R&D processes to ensure owned studies are on track Key, pivotal 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 Performs site visits when requested to assist with monitoring activities in the field, unblinded monitoring 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 excellent knowledge of finance systems. Ensures all trial documentation is created, distributed, maintained and tracked, using electronic storage facilities (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 Responsible for end of trial site file and TMF reviews when requested Is responsible 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 efficiently 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 excellent 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 technologies 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, Desired experience within the Pharmaceutical Industry / CRO environment with a good knowledge of Clinical Research processes including ICH GCP Excellent communication skills and an ability to multi task PC Literate - Intermediate Word, Excel, Powerpoint, Lotus Notes key words clinical trials administrator, CTA, in house CRA, document management, adminiatrator To apply for this position please email your CV to marc.joseph@chiltern.com - marc.joseph@chiltern.com. Salary Negotiable Position Type Permanent Full Time Contact Email Marc Joseph - marc.joseph@chiltern.com 01753 216664

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