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SeniorSite Start Up & Regulatory Specialist - Serbia Nr ref.: /JOBS.pl ~~ From our early days as an academic CNS research organization in the 1980s, to the formation of INC in 1998, to where we are today, we've continued to improve what we do. At INC Research we appreciate the importance of having experts dedicated to the set up stages of the studies, and for this reason we have a devoted Study Start Up team with departments focused upon Site Identification and Feasibility, Site Contracts, Ethics and Regulatory and Patient Recruitment. As a member of our Study Start Up team you will traverse all therapeutic areas and phases, providing your expertise at this vital period of time in the study. This expertise at this critical time has resulted in the average study start up time four weeks faster than industry standard. We are currently looking to strengthen our Ethics and Regulatory department in the Serbia and are seeking an experienced Site Start Up & Regulatory Specialist to be based in our office in Belgrade. A brief summary of duties you will be involved in as a Senior Site Start up Specialist •Reviewing essential document packages for site activation •Preparation and submitting of Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required •Reviewing Informed Consent Forms •Independently administers and negotiates site contracts that support projects within Clinical Operations in accordance with sponsor and Company requirement Qualifications To succeed in this role you will need the following skills/experience: •Previous experience in clinical research including submissions experience •Previous experience in contract/budget negotiations •Knowledge of local regulatory requirements/guidelines, such as Code of Federal Regulations and European Union Directive as well as any applicable rules applicable locally Why choose us: It takes skill and passion to develop medicines the way we do. Don't worry - if you've got the passion part, we'll help you develop the skills you need to enhance every aspect of your career in the clinical research industry. We've got an attitude at INC: "Can do, I own it." Absolutely everyone has ownership of what they do here. And because we're given the freedom and responsibility to really own our projects, we can take them to new levels. And that means we can take our careers wherever we want them, too. "INC Research we're ranked "Top CRO" to work with in the CenterWatch 2013 Investigative Site Relationship Survey (a biannual survey of over 2,000 sites worldwide)." What happens next: If your application is successful you will be contacted by one of our dedicated recruiters who will arrange a suitable date and time to speak to you further about this opportunity. Kontakt: Aplikuj teraz Ogłoszenie pochodzi z serwisu Jobs.pl .

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