Clinical Project Scientist
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Janssen Research and Development, L.L.C., a member of Johnson and Johnson's Family of Companies, is recruiting for a Clinical Project Scientist, Immunology to be located in Spring House, PA.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases.
Please visit http://www.janssenrnd.com/ for more information.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The focus of the Clinical Project Scientist is to support Study Responsible Physician (SRP) &/or Study Responsible Scientist (SRS) in various clinical research tasks associated with assigned Immunology Development clinical trials. Scope of work will include tasks associated with the execution, monitoring, and reporting of late-phase clinical trials evaluating therapeutics in Inflammatory Bowel Disease. The range of tasks will include activities assigned by the SRP/SRS and may vary to some degree depending on the therapeutic area and trial-specific requirements.
Responsibilities include but are not limited to:
• Assist with activities as assigned by the Study Responsible Scientist or Study Responsible Physician, which support the execution, monitoring, and reporting of clinical trials.
• Member of the cross-functional clinical trial team for assigned studies.
• Participate in the development of clinical study documents (e.g., protocols, informed consent documents, case report forms).
• Support activities related to the start-up and execution of new clinical trials.
• Perform clinical data review and assist in the preparation of clinical safety presentations and reports.
• Support monthly medical monitoring data review activities.
• Assist with tracking of safety events, review of new SAEs, and composing adverse event Narratives.
• Assist in the preparation of the clinical content of drug safety documents and reports such as the investigator brochures, DSURs, and other regulatory response documents.
• May assist with managing other vendor activities such as laboratory, histology or imaging.
• Other activities as determined by study team and phase of trial (start-up, study execution and close out).
• A minimum of a Bachelor’s degree (or equivalent) required; A Bachelor's in a scientific or clinical discipline; nursing is desirable.
• A minimum of 3 years of relevant or clinical research work experience is preferred.
• Proficient knowledge of medical terminology is required.
• Strong organizational skills, written and verbal communication skills are required.
• Excellent time management skills with the proven ability to plan and track deliverables and timelines are required.
• Individual must work well in a dynamic environment and be able to prioritize and respond to changing needs of the business.
• Up to 10% domestic travel may be required.
United States-Pennsylvania-Spring House-
Janssen Research & Development, LLC (6084)
Clinical Research non-MD