Clinical Research Associate
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A client of ours is looking for a CRA to do some monitoring in and around London on a part time basis for a 12 mmonth contract.Key RequirementsA minimum of Bachelor degree in a relevant fieldA minimum of 5 years clinical research experienceFluent written and spoken EnglishMain Functions Co-ordination of assigned clinical trial activities for specific studies in line with ICH-GCP, applicable regulatory requirements and guidelines, SOPs, study protocols and study-specific procedures.Primary Responsibilities Perform activities according to Sponsor SOPs (if applicable). Perform site monitoring and close out visits according to the study monitoring plan. Prepare reports of monitoring and close-out visits and follow-up on outstanding issues according to the timelines specified. Collect and maintain essential documents as required by ICH-GCP, and/or Sponsor SOPs. Preparation and review of study related documentation as applicable (Patient Information Leaflets, Informed Consent Forms, Protocols, Case Report Forms and others). Assist with preparation of Regulatory Authority and Ethics Committee submissions if required. Monitoring and reconciliation of Serious Adverse Events (SAEs). Tracking of clinical trial activities. Identification and communication of scientific misconduct.If you feel that you would suit well to this role, please get in touch with Tokay Aderiye at X4 Group on 02078127700 as soon as possible and send an updated CV to [email protected]
clinical research associate / clinical trial manager / clinical project manager / clinical trial project manager / senior clinical research associate / clinical research associate / lead clinical research associate / clinical research associate II / CRA 2 / CRA 1 / CRA I / Senior CRA / lead CRA / clinical study manager
