Clinical Research Associate II - Shockwave Reducer (Remote)

Johnson & Johnson MedTech; Santa Clara (CA); Remote; USD 80,000 - 110,000; Full time

Job summary

A leading company in healthcare innovation is seeking a Clinical Research Associate II to manage global clinical trials for their Shockwave Reducer device. This fully remote position requires a Bachelor's degree and at least 2 years of experience in clinical research. The role involves ensuring compliance with protocols, conducting site visits, and managing study documentation. Ideal candidates will have strong communication skills and a detail-oriented mindset, with a preference for those certified in ACRP or SOCRA.

Qualifications

• At least 2 years of relevant industry experience supporting clinical research in a Sponsor role.
• Basic understanding of peripheral and coronary artery disease and therapies preferred.
• ACRP or SOCRA certification preferred.

Responsibilities

• Facilitate in-house setup, activation, maintenance, and closure of clinical trials.
• Conduct site visits to ensure protocol compliance and accurate data collection.
• Manage investigator contracts, budgets, and payments.

Skills

Communication

Attention to detail

Organizational skills

Ability to work independently

Education

Bachelor’s degree in science or healthcare

Tools

EDC Data Management Systems

Job description

Clinical Research Associate II - Shockwave Reducer (Remote)

Join to apply for the Clinical Research Associate II - Shockwave Reducer (Remote) role at Johnson & Johnson MedTech.

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:

New Brighton, Minnesota, United States of America; Santa Clara, California, United States of America

Job Description

Johnson & Johnson is hiring for a Clinical Research Associate II - Shockwave Reducer (Remote) to join our team. The position is FULLY REMOTE and can sit anywhere in the US.

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/.

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. We’re 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 Clinical Research Associate II (CRA II) is responsible for facilitating in-house setup, activation, maintenance, and closure of Reducer device global clinical trials while gaining experience in clinical trial management processes. The CRA II will work closely with Investigators, Site Personnel, and Vendors to ensure compliance with protocol and overall clinical objectives. In collaboration with the Clinical Research Manager, the CRA II maintains consistent CRF data quality and discrepancy interpretation across sites. The CRA II will develop a basic understanding of the disease and indication.

Essential Job Functions

• Participate in study design and study setup activities
• Conduct site visits (pre-study, initiation, interim, and close-out) to ensure protocol compliance, accurate data collection, and proper study conduct
• Review monitoring visit reports for completeness
• Support development of study training and provide site personnel training
• Develop study tools and guidelines for study sites
• Interact with field monitors/CRO CRAs, investigators, and study coordinators to manage study issues
• Draft and review informed consent forms for compliance and clarity
• Coordinate and review regulatory documents from study sites
• Ensure study records are auditable in-house
• Author internal documents and possibly sections of clinical study reports
• Manage investigator contracts, budgets, and payments
• Communicate trial status to the team
• Develop or revise SOPs or work instructions as needed
• Other duties as assigned

Requirements

• Bachelor’s degree in science or healthcare with at least 2 years of relevant industry experience supporting clinical research in a Sponsor role
• Excellent verbal and written communication skills
• High attention to detail and organizational skills
• Basic understanding of peripheral and coronary artery disease and therapies (preferred)
• Knowledge of GCP, FDA, ISO regulations
• Ability to travel 10-20% domestically and internationally
• Experience with EDC Data Management Systems
• Ability to work in a fast-paced environment managing multiple priorities
• ACRP or SOCRA certification (preferred)
• Ability to work independently or as part of a team, adaptable to changing requirements