Clinical Science Specialist

At Kforce Clinical Research, we dont just offer jobs. We offer a rewarding career experience, complete with professional development opportunities and a great benefits package! We are intelligent business partners to some of the worlds most valued pharmaceutical companies and have evolved to create models of operational excellence that incorporate Lean and Six Sigma philosophies. Using these tools, Kforce is able to better plan and anticipate work loads and thus minimize the peaks of work that can swamp you. This allows you to stay just as dedicated and still strike a balance between work and home. Currently, one of our top clients is in search of an exceptional Clinical Science Specialist in Nutley, NJ. The Clinical Scientist will assist the clinical science leader in all areas of project and study planning, evaluation, documentation including IND and annual report, clinical NDA preparation and protocol preparation. The Clinical Scientist will be responsible for at least one study (in all aspects). Specific Accountabilities: * Assist in the timely medically and scientifically sound development of the clinical portions of a product development plan (PDP), the quality and timely preparation of all PDM documents submitted for approval GCP, Clinical Operating Guidelines, and Standard Operating Procedures are followed within PDC * Liaise with appropriate departments inside and outside PDC to define the timing of discussion with the FDA and other regulatory bodies on format of clinical NDA and submission issues * Prepare clinical progress reports for regulatory agencies before they are reviewed by line-managers and assure the consistency of labeling and package insert (clinical section) with the database * The preparation and contents of annual reports and safety updates and ensures corrects data interpretation including interim and Final Study Reports before they are approved and assume protocol authorship Requirements: Clinical Science Specialist to Include Education: * B.S. Degree or equivalent scientific qualification is minimal; an M.S. or advanced research experience is preferred * Two to five years of clinical research experience, preferably in industry as a headquarter clinical research associate and/or coordinator with an overall knowledge of drug development process Due to the precise requirements of this position, we will only be contacting candidates that meet all of the listed criteria. Kforce Clinical Research has been serving the pharmaceutical industry since 1988. We are truly a career destination and the employer of choice for skilled, dedicated professionals like you. At Kforce, one of our core principles is: Great People = Great Results! This means that we will work to find you the right career match through exceptional customer service, a disciplined process, and personal respect. If you are qualified and interested in the excellent career opportunities we have for you, apply today!

Please refer to job code 1696NRC950575T199 when responding to this ad.

Category:	Healthcare/Social Services
	> Other Healthcare
Location:	Nutley, NJ
County:	Essex County
ZIP Code:	07110
Pay Rate:	Open
Job Terms:	full time
Company:	Kforce Inc.
Phone:	email only please
Fax:	email only please