Requirement SourcePoint | By Innovative

Requirement Number: 5592

Recruiter	Bill Angelo
Requirement Type	Contract
Requirement Category	Clinical R&D - Safety Reviewer
Location	Abbott Park IL
Start Date	05/15/2007
End Date	12/31/2007
Number of Openings	1
Max Pay Rate or Salary	$35.00
Job Description	REQUIRES 3-5 YEARS EXPERIENCE Responsibilities include medical review, which involves in-house review of Case Report Forms (CRFs) including query resolution and addenda writing, QA of data listings. May manage the activities of regional contract CRAs, and organizes the files and budgets associated with several clinical studies. Provides medical support which may include: Adverse Event Reporting - the investigation and reporting of medical product experiences, in depth investigation of medical adverse events and works with Medical Affairs, Clinical, and Regulatory Affairs in the preparation of documentation on adverse events for the FDA; or Medical Communication which includes writing standard and custom responses to communication requests, in-depth assistance to the medical and lay community by responding to inquiries with medical/scientific information that is more complex and requires more data than is supplied in the package insert or the standard letter database. Off-label information would be disseminated at this level. May provide training internally and at investigator meetings on safety issues, responsible for serious adverse events and CRF completion, writing study summaries, and review protocols, study summary investigator brochures and IND annual updates for safety data verification. BS Preferred. Candidate should be an R.N. with medical clinical experience of approximately 5 years, in addition to 3-5 years of clinical research experience. This job will require a candidate experienced in serious adverse event analysis and reporting (SAEs) for a large ex-US outcome trial.

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