Clinical Research Associate

Feladatok: Full ownership of study managementSite visiting - coordinating and overseeing the execution of studies and clinical trial;Investigators & sites - responsibility for the successful management of all site-related activities from feasibility through maintenance till close-out including Investigator relationship management, document management, site stock monitoring, sample shipment, issue detection, reporting, resolution;Compliance - ensuring SOP and regulatory compliance for site activities as well as data integrity and validity, assistance during audit/inspection;Regulatory and ethics - submission package compilation, deficiency response, amendment submission;Contract and payment - contractnegotiation, payment preparation;Vendors - involvement in specification, procurement, and commissioning of supplies.Required Attributes:Experience in investigator site management - either in clinical pharmacology trials, or preferably interventional human research trials (i.e. trials w/o investigational drug administration) including feasibility, site initiation, monitoring and close-out, recruitment support, source data verification, query management, plus appropriate document management;Regulatory knowledge - familiar with local regulatory requirements;Life science background is desirable, but not absolutely necessary (experience in clinical research weighs in more);Language knowledge - fluency in Hungarian and English including technical terms;IT - strong user-level knowledge of MS Office;Interpersonal skills - proactive, enthusiastic team player;Flexibility - the ability to tolerate a fast-paced working environment and rapidly changing circumstances. Elvárások: Full ownership of study managementSite visiting - coordinating and overseeing the execution of studies and clinical trial;Investigators & sites - responsibility for the successful management of all site-related activities from feasibility through maintenance till close-out including Investigator relationship management, document management, site stock monitoring, sample shipment, issue detection, reporting, resolution;Compliance - ensuring SOP and regulatory compliance for site activities as well as data integrity and validity, assistance during audit/inspection;Regulatory and ethics - submission package compilation, deficiency response, amendment submission;Contract and payment - contractnegotiation, payment preparation;Vendors - involvement in specification, procurement, and commissioning of supplies.Required Attributes:Experience in investigator site management - either in clinical pharmacology trials, or preferably interventional human research trials (i.e. trials w/o investigational drug administration) including feasibility, site initiation, monitoring and close-out, recruitment support, source data verification, query management, plus appropriate document management;Regulatory knowledge - familiar with local regulatory requirements;Life science background is desirable, but not absolutely necessary (experience in clinical research weighs in more);Language knowledge - fluency in Hungarian and English including technical terms;IT - strong user-level knowledge of MS Office;Interpersonal skills - proactive, enthusiastic team player;Flexibility - the ability to tolerate a fast-paced working environment and rapidly changing circumstances.Egészségügyi szakember

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