Freelance Site Start Up & Regulatory Specialist - Italy Nr ref.: /JOBS.pl We are currently looking to strengthen our Ethics and Regulatory department in Italy and we are seeking an experienced SSU & Regulatory Specialist on a contract basis to be based regionally from home. 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. Key Responsibilities: A brief summary of duties you will be involved in as a Contractor SSU & Regulatory 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 Qualifications We are seeking candidates with the following key attributes: To succeed in this role you will need the following skills/experience: • Previous experience in clinical research including submissions experience • 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 has been ranked as "Top CRO to work with" among large global CROs in the biannual CenterWatch Global Investigative Site Relationship Survey. INC is the only CRO to rank consistently among the top three CROs in all seven CenterWatch site relationship surveys conducted since 2007" 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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