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 Serbian team with an individual with experience in both Ethics and Regulatory and Site Contract Negotiation activities to be office based in Belgrade.
A brief summary of duties you will be involved in as a Site Start up Specialist I
- 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 Form
- Administering all contract management processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level.
•- Assists with negotiation and preparation of contracts, budgets, and related documents for participation in industry-sponsored clinical trials.
•- Reviews contracts for completeness and accuracy, and ensures that corrections are appropriately made and documented.
To succeed in this role you will need the following skills/experience:
• Previous experience in clinical research including submissions experience and site contract negotiation.
• 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.
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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