Principal Clinical Research Associate - Shockwave Medical (Remote)

Lensa; Santa Clara (CA); Remote; USD 105,000 - 170,000; Full time

Job summary

A leading healthcare company is seeking a Principal Clinical Research Associate to manage clinical studies for innovative treatments. This remote role requires extensive experience in clinical research and project management skills, overseeing compliance, data integrity, and study objectives. Join a team dedicated to pioneering advancements in healthcare solutions.

Benefits

Health insurance

Retirement plans

Paid time off

Competitive, performance-based bonuses

Qualifications

• Minimum 10 years supporting clinical research, with at least 1 year managing trials.
• Thorough knowledge of GCP, FDA, ISO regulations.
• Preferred certifications: ACRP or SOCRA.

Responsibilities

• Manage global clinical studies and oversee project activities and vendors.
• Conduct site visits to ensure protocol compliance.
• Lead data analysis, document preparation, and regulatory submissions.

Skills

Project Management

Communication

Attention to Detail

Education

Bachelor’s Degree in a scientific field

Tools

EDC systems

Job description

Principal Clinical Research Associate - Shockwave Medical (Remote)

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Lensa is the leading career site for job seekers at every stage of their career. Our client, J&J Family of Companies, is seeking professionals. Apply via Lensa today!

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 Principal Clinical Research Associate – Shockwave Medical (Remote) to join our team.

We are developing the next generation of smarter, less invasive, more personalized treatments, pioneering the development and commercialization of Intravascular Lithotripsy (IVL) for complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for treating atherosclerotic cardiovascular disease using sonic pressure waves.

Position Overview

The Principal CRA manages global clinical studies, overseeing project activities, vendors, and study conduct in compliance with applicable standards. This role requires minimal oversight, frequent communication with stakeholders, and is vital to our business success.

Essential Job Functions

• Organize, communicate, and evaluate clinical study objectives.
• Participate in study design, documentation, and site/vendor selection.
• Conduct or oversee site visits to ensure protocol compliance and data integrity.
• Develop training tools, interpret data, manage sites, and track study progress.
• Manage project timelines, budgets, and vendor performance.
• Lead data analysis, document preparation, and regulatory submissions.
• Coordinate investigational product management and training.
• Ensure quality and compliance, review adverse events, and implement corrective actions.

Requirements

• Bachelor’s Degree or equivalent in a scientific field.
• Minimum 10 years supporting clinical research, with at least 1 year managing trials.
• Ability to travel 10-20% domestically and internationally.
• Thorough knowledge of GCP, FDA, ISO regulations.
• Experience with EDC systems and device clinical studies, including IDE trials.
• Preferred certifications: ACRP or SOCRA.
• Strong project management, communication, and attention to detail skills.

Pay Transparency

• Salary range: US: $105,000 - $169,050 / Bay Area: $121,000 - $194,350
• Competitive, performance-based bonuses and benefits including health insurance, retirement plans, and paid time off.

For more benefits information, visit https://www.careers.jnj.com/employee-benefits.

Johnson & Johnson is an Equal Opportunity Employer. We encourage applications from protected veterans and individuals with disabilities. For accommodations, contact [e-mail].