3/22/16- Site Start-Up Specialist

3/22/16- Site Start-Up Specialist

3/22/16- Site Start-Up Specialist

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Accentuate Staffing is currently looking for a Site Start-Up Specialist to join a global company in the Raleigh area.  This is a 6 month contract position with a Global CRO.  Great opportunity for a recent graduate that has an interest in the CRO field.

Responsibilities:

-Performs assigned activities within the country that lead to start-up of investigative sites in all phases of clinical trials.
-Responsible for providing delivery and expertise in one or more of the following functional areas: investigator site contracts, ethics and regulatory submissions, and review and finalization of essential documents required for site initiation.
-Ensures local activities are undertaken in accordance with agreed timelines, allocated budgets, and required quality standards.
-Ensures an efficient start-up process on assigned studies.

Requirements:

-BA/BS degree in the science/health care field, legal degree, or equivalent combination of education and experience.
-Knowledge of and a clear understanding of the overall drug development process.
-Knowledge of local regulatory requirements/guidelines, such as Code of Federal Regulations and European Union Directive as well as any applicable rules applicable locally.
-Demonstrated clinical development and clinical research knowledge.
-Excellent verbal, interpersonal, and written communication skills.
-Good record retention and customer service skills.
– Proficient in the use of computer and software systems (e.g., Excel). Ability to successfully support internal and external customers.

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