Senior Clinical Research

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Senior Clinical Research Associate (CRA)Clinical (R&D dpt.), permanent role, Stirling £45,000 - £50,000 basic dependent on experience Role DescriptionWorking as part of the Clinical team you will have significant clinical project responsibility for planning and conducting all clinical studies to support product development, regulatory submissions, and post-market evaluation for In Vitro Diagnostic products. Key ResponsibilitiesTechnical lead for ensuring the clinical trial study design meets the needs of the product launch plan.Identify appropriate clinical sites and manage effective clinical relationships. Liaise with the Principal Investigator and clinical operations staff as required.Prepare, edit, review and submit clinical documentationComplete and compile all necessary research, documentation and information to gain appropriate regulatory and ethical committee approval where required e.g. IRAS, HRA and R&D submissions.Clinical lead to ensure studies are planned, implemented, conducted, monitored and reportedMonitor clinical trials to ensure compliance to the study protocol, clinical business processes, applicable regulations and the principles of ICH-GCPLead pre-study initiation, interim monitoring and close out visits as required.Comply with appropriate ICH GCP standards and relevant sections of the IVD Directive and US Code of Federal regulations, Title 21 (21 CFR).Up-date and review business processes and clinical procedures to meet regulatory and business needs.Manage and mentor more junior members of the teamEssential SkillsA Degree in Life Sciences, Health Sciences or related field, or professional qualification such as nursing, or in-depth experience in performing a Clinical Research Associate role preferably with Medical Devices or In Vitro Medical Devices.Significant work experience within either a hospital, medical/research centre environment, Contract Research Organisation or Pharmaceutical company.Proven track record of adherence to ICH-GCP and applicable local regulatory requirements during the conduct of clinical trials.Ability to independently create and drive the development of clinical trial related documents and materials.Ability to independently perform pre-study initiation, interim monitoring and close out visits as required.Ability to mentor, train, supervise and support junior members of the team.Excellent communication skills, including the ability to present complex information to both clinical and non-clinical disciplines.Willingness and ability to travel. Driving license.Desirable SkillsKnowledge of statistics.Knowledge of FDA regulatory requirements.Experience across a wide range of clinical indications/therapeutic areas. m.zaatriATrealstaffing.com To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales