Registered Dietitian / Registered Nurse

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. 

0-3 Years Experience Level.

Education/background: 

Bachelor's degree with related health science background required. (Registered Dietitian or Registered Nurse strongly preferred); 1-2 years clinical and/or other related experience; some industry experience desirable; basic understanding of domestic and global regulations and current clinical practices; clinical knowledge to apply to adverse event data collection and/or medical/product assessments; computer proficient (Windows, Word, Excel) and proficient in specific adverse event databases (as applicable); able to present case data, medical and scientific data orally and in writing.

All your information will be kept confidential according to EEO guidelines.