Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms RSS Feed RSS Feeds RSS Feed PharmiWeb Candidate Blog RSS Feed PharmiWeb Client Blog

Job Details

Freelance Site Start Up & Regulatory Specialist - Italy

Company: INC Research
Location: Italy
Reference: 16003985
Closing Date: 21 Nov 16
Type: Contract
Salary (£): Negotiable

Job Summary:

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 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


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.

Apply for this job: Freelance Site Start Up & Regulatory Specialist - Italy

Contact Information:

Address:  European Head Office
River View, The Meadows Business Park,
Station Approach,
GU17 9AB
Tel:  +44 (0) 1189 335 300
Website:  Visit Our Web Site

Share | | |
Site Map | Privacy & Security | Cookies | Terms and Conditions is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.