Clinical research associate

Hely: Budapest
Cég: Molekuláris- Ujjlenyomat Kutató Központ Nonprofit Kft.
Kategória: Egészségügy, Gyógyszeripar

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. 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. Have experience in process and/or SOP development;Can demonstrate site management skills. A versatile range of work packages, including: Higher-than-usual cafeteria allowance, Private health insurance, Yearly performance incentives, 30 guaranteed annual vacation days, Professional training opportunities.Home office option, 1-2 days per week.Possibility to be based in our Szeged office.Team activities and team-building events.A dynamic work environment with the opportunity to engage in a rapidly evolving and innovative field.Long-term opportunities alongside highly qualified and motivated professionals.An international work environment with professional development opportunities.A solution-oriented atmosphere with the chance to contribute to the success of a dynamic and growing organization.

Címkék: Employee status, University

profession.hu - 17 napja

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