Company: INC Research
Closing Date: 16 Mar 17
Salary (£): Negotiable
Do you want to be part of a global top 10 CRO? INC Research is a full-service clinical research organization, providing the full range of Phase I to IV clinical development services for the world’s pharmaceutical, biotech and medical device industries. We do this across six continents. We believe that therapeutic and operational experience forms the foundation for taking medicines successfully through clinical development.
We are currently looking to strengthen our Ethics and Regulatory department in France and are seeking a Site Start Up & Regulatory Specialist to be based from our Issy Les Moulineaux office.
Due to continued growth at INC Research this new exciting blended position will encompass both the Site Start up and Regulatory activities as well as Site Contracts Activities.
A brief summary of duties you will be involved in as a Site Start up and Regulatory / Site Contracts Specialist:
•Independently administers and negotiates site contracts that support projects within Clinical Operations in accordance with sponsor and Company requirement
•Facilitates contract management functions with internal and external legal, finance, and clinical operations departments
•Reviews essential document packages for site activation
Prepares and submits local regulatory authorities or hospital approval submissions as required
Reviewing Informed Consent Forms
•Serves as communication liaison between site contracts staff and internal and external customers
To succeed in this role you will need the following skills/experience:
BA/BS degree in the science/health care field, legal degree, or equivalent combination of education and experience.
Moderate contracts management or study start up and regulatory experience
Experience in a contract research organization, pharmaceutical, or biotechnology company preferred
Knowledge of and understanding of the overall drug development process. Knowledge of local regulatory requirements/guidelines, such as Code of Federal Regulations and European Union Directive.
Demonstrated clinical development and clinical research knowledge.
Excellent verbal, interpersonal, and written communication skills in both local and English language
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.
INC Research Europe
Királyhágó tér 8-9, 2th floor, 1126 Budapest, Hungary
|Tel:||+36 1 489 48 56|
|Website:||Visit Our Web Site|
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