Assistant, Clinical Research - Clinical Operations
Location:
, New Jersey
Posted:
March 11, 2017
Reference:
4589161221-en-us

Johnson & Johnson Consumer Inc., is hiring an Assistant, Clinical Research - Clinical Operations to be located in Skillman, NJ.  


Johnson & Johnson Family of Companies touches more than a billion people’s lives each day through our health care products and services, our corporate giving, and the volunteer efforts of our employees. The Johnson & Johnson Group of Consumer Companies develop and market beloved brands that address the needs of consumers and health care professionals worldwide. Our portfolio ranges across several distinct business units: Baby Care, Oral Care, Compromised Skin Care, Beauty, Feminine Care, and Over-The-Counter (OTC) products.

 

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

 

The Assistant, Clinical Research will:

  • Have responsibility for all operational aspects of routine clinical safety studies based on ICH guidelines and SOP requirements.
  • Initiates requests for test panels after receipt of test request and formulas
  • Ensures timely conduct of the test panel studies from initiation to finalization of the clinical study report.
  • Ensures study updates are made in the global tracking tool
  • Ensures annual contracts are in place
  • Ensures annual site training (and additional trainings as needed) is completed
  • Ensures compliance with internal SOPs and applicable GCP regulations
  • Ensures that all Adverse Events (AEs), Serious Adverse Events (SAEs), Product Quality Complaints (PQCs) and Special Situations (SSs) are reported within reporting timelines and documented appropriately
  • Tracks product samples internally to ensure they are ready for shipment to site for study start.
  • Reviews periodic monitoring visit reports
  • Reviews annual protocol and other essential study documentation
  • Ensures timely and accurate filing of study documents in the trial master fill
  • Identifies and escalates study issues to management
  • Collaborates with the Study Director and other members of the clinical operations group as well as with cross-functional partners
  • Attends bi-weekly North America Clinical Operations meetings.


Qualifications

  • A minimum of an Associate Degree with minimum 2 years of industry experience is required or H.S. diploma with a minimum of 8 years of industry experience required.
  • Previous experience with study coordination is preferred.
  • Experience with ICH/GCP guidelines is required.
  • This position may require up to 10% domestic travel.
  • This position is required to be based in Skillman, NJ.


Primary Location
United States-New Jersey-Skillman
Organization
J & J Consumer Inc. (6101)
Job Function
Clinical Trial Coordination

A little about us:
Johnson & Johnson cares for the world - bringing innovative ideas, products and services to advance the health and well-being of people.

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