Senior Clinical Research Associate - (US-CA-San Diego - 92199)

Minimum Education: None
Job Type: Full Time
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Responsibilities: General On-Site Monitoring a)Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the studyb)Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirementsc)Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document reviewMonitor data for missing or implausible datad)Ensure the resources of the Sponsor and Covance are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Covance travel policye)Prepare accurate and timely trip reportsUndertake feasibility work when requestedRecruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor as assignedNegotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assignedComplete process of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEsIndependently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by managementAssist with training, mentoring and development of new employees, e.gco-monitoring Co-ordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assignedPerform other duties as assigned by management.Requirements: University/College degree highly desireable (life science preferred)In lieu of the above requirement, candidates with four (4) or more years of relevant clinical research experience in pharmaceutical or CRO industries will be consideredThorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements in other countriesThorough understanding of the drug development processFluent in local office language and in English, both written and verbalThorough knowledge of Covance S.O.P.s regarding site monitoring.Experience: of four (4) years of clinical research monitoring experience.

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