Sr. Clinical Research Associate - Shockwave Medical

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
R&D Operations

Job Sub Function:
Clinical Trial Project Management

Job Category:
Professional

All Job Posting Locations:
Santa Clara, California, United States of America

Job Description:

Johnson & Johnson is hiring for a Sr.

CRA – Shockwave Medical to join our team.

The position is FULLY REMOTE and can sit anywhere in the US.

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Ready to join a team that’s pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease.

Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.

Position Overview

The Sr.

Clinical Research Associate (Sr.

CRA) will be responsible for establishing, managing and meeting milestones of clinical studies in compliance with applicable clinical and regulatory standards and in alignment with business needs.

They will be accountable for clinical project management activities, for coordination with cross-functional counterparts and contract research organizations (CROs) in global studies.

This position requires strategic, project and resource management responsibilities for the assigned clinical program(s) to evaluate the safety and effectiveness of interventional products.

This work is accomplished with moderate supervision and requires a motivated, self-starter who can work independently once projects are assigned.

Essential Job Functions


* Participate in the design and execution of global studies for regulatory submissions, reimbursement and product adoption, including clinical study documents (protocol, case report forms, etc.), study implementation and data management.


* Manage study preparation, activation, enrollment, submission, maintenance and closure activities.


* Participate in administrative activities associated with the clinical department including procedures, training of key personnel and preparation and maintenance of objectives and budgets.


* Interface with representatives from key functional groups to drive product development within core teams, and clinical wide or cross-departmental initiatives.
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