About Collabera:

Established in 1991, Collabera is one of the fastest growing end-to-end information technology services and solutions companies globally. As a half a billion dollar IT company, Collabera's client-centric business model, commitment to service excellence and Global Delivery Model enables its global 2000 and leading mid-market clients to deliver successfully in an increasingly competitive marketplace.

With over 8200 IT professionals globally, Collabera provides value-added onsite, offsite and offshore technology services and solutions to premier corporations. Over the past few years, Collabera has been awarded numerous accolades and Industry recognitions including.

• Collabera awarded Best Staffing Company to work for in 2012 by SIA. (hyperlink here)
• Collabera listed in GS 100 - recognized for excellence and maturity
• Collabera named among the Top 500 Diversity Owned Businesses
• Collabera listed in GS 100 & ranked among top 10 service providers
• Collabera was ranked:
• 32 in the Top 100 Large Businesses in the U.S
• 18 in Top 500 Diversity Owned Businesses in the U.S
• 3 in the Top 100 Diversity Owned Businesses in New Jersey
• 3 in the Top 100 Privately-held Businesses in New Jersey
• 66th on FinTech 100
• 35th among top private companies in New Jersey
http://www.collabera.com/about_us/accolades.jsp

Collabera recognizes true potential of human capital and provides people the right opportunities for growth and professional excellence. Collabera offers a full range of benefits to its employees including paid vacations, holidays, personal days, Medical, Dental and Vision insurance, 401K retirement savings plan, Life Insurance, Disability Insurance.

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.