& 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)
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
- 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
- Ensures timely and accurate filing of study
documents in the trial master fill
- Identifies and escalates study issues to
- Collaborates with the Study Director and other
members of the clinical operations group as well as with cross-functional
- Attends bi-weekly North America Clinical
- 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
- Experience with ICH/GCP guidelines is
- This position may require up to 10% domestic
- This position is required to be based in
United States-New Jersey-SkillmanOrganization
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.