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CLINICAL RESEARCH ASSOCIATE

This position is responsible for project management and study site management from site selection toinitiation until monitoring and close-out of assigned clinical study studies in accordance with tigermedor sponsor standard operating procedures (sops), international conference on harmonization goodclinical practice standard (ich-gcp), clinical practice standard (gcp) and other applicableregulations; the position is responsible for ensuring that all data generated by the assigned sites is of high quality,on time and within budget. 2. responsibilities: study site selection, initiation (siv) and clinical monitoring; provide ongoing training to site staff with regards to ich-gcp, gcp, study protocol and requirements; conduct site initiation to ensure that the site has a thorough understanding of the study protocol and requirements; ensure timely collection of essential documents in compliance with protocol and regulations at study start-up, during and at study close-down. maintain and update these documents in investigator files, trial master files; prepare/complete study records’ archiving according to protocol and sponsor requirements; ensure safety information is disseminated to all sites according sop and applicable regulations; ensure sae is reported within the timeline in compliance with sops and applicable regulations; finalize budget and obtain signed contract from site, prior to site initiation visit; ensure study payment schedule is executed and retain relevant documents/receipts; update and maintain study tools/systems in a timely manner. 3. qualifications: bachelor ...


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