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. 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 Clinical Research Associate II (CRA II) is responsible for facilitating in-house set up, 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

• May participate in study design and study set up activities

• May conduct site visits (pre-study, initiation, interim and close-out visits) to ensure protocol compliance, accurate and thorough data collection, and appropriate study conduct

• Participates in the review of monitoring visit reports for completeness

• Supports development of study training and may provide study site training to site personnel

• Provides study training to internal employees as applicable

• Assists in development of CRF design, CRF guidelines and supports database development when applicable

• Develops study tools and guidelines to be utilized by study sites

• Develops basic knowledge of the process used to evaluate and select potential investigators and sites

• Develops basic knowledge of the process used to evaluate and select potential vendors as applicable

• Interacts with field monitors/CRO CRAs, investigators and study coordinators through frequent communication (written and verbal) and maintains effective management of study issues

• Drafts informed consents as applicable

• Reviews site’s informed consent forms against the consent template for presence of all GCP requirements and protocol specific information and revises as needed. Also reviews the consent for accuracy and ensures that the consent is written in language that subjects will understand

• Coordinates and reviews regulatory documents from study sites; ensures completeness and accuracy, facilitates translation as needed

• Ensures study records are auditable in-house

• Responsible for authoring internal documents, and may author portions of clinical study reports or clinical evaluation reports

• Develops basic knowledge of the investigator contract, budget, and payment process including legal language and document structure as it impacts assigned studies

• May be responsible for initiating and tracking quarterly site payments and reconciling study invoices

• Communicates status of trial to manager and team

• May be responsible for development or revision of SOPs or work instructions

• Appropriately represents functional area

• Other duties as assigned

Requirements

• Bachelor’s degree in science or healthcare with a minimum of 2 years of medical device industry experience directly supporting clinical research in a Sponsor role

• Must have excellent verbal and written communication skills

• High attention to detail and organizational skills are necessary

• Basic understanding of peripheral and coronary artery disease and therapies preferred

• Working knowledge of GCP, FDA, ISO and other applicable regulations

• Ability to travel 10-20% domestically and internationally

• Experience with EDC Data Management Systems

• Ability to work in a fast-paced environment while managing multiple priorities

• ACRP or SOCRA clinical research certification preferred

• Operate as a team and/or independently while demonstrating flexibility to changing requirements

Pay Transparency:

• The anticipated salary range for this position is US: $74,000 - $119,600/ Bay Area: $86,000 - $138,000

• The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

• Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

• This position is eligible to participate in the Company’s long-term incentive program.

• Employees are eligible for the following time off benefits:

  • Vacation – up to 120 hours per calendar year

  • Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year

  • Holiday pay, including Floating Holidays – up to 13 days per calendar year

  • Work, Personal and Family Time - up to 40 hours per calendar year

• Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

$74,000 - $119,600

Additional Description for Pay Transparency:

Push the boundaries of science to transform health—and your career.

Join us and advance life-changing treatments for people who need them most. At Johnson & Johnson, our focus is on improving global health equity and developing MedTech and pharmaceutical innovations that impact the future of health. Using AI and robotics to transform surgery or helping data scientists and clinicians formulate new ways to diagnose and treat disease, this work may sound like sci-fi, but it’s all science, all real, and could be your career. Whatever your background, skills, or career goals, there’s a place for you to help solve some of the world’s most pressing health challenges with us.

Accelerate your career while changing the world.

Each of our broadly-based family of companies offers an inclusive and empowering culture and employee benefits (like paid time off to volunteer, transgender-inclusive and same-sex partner health insurance coverage, and more) designed to help you live your best life, however you define it. And our best-in-class learning and development approaches, mentorship, and access to innovators across the world will help you grow your skills and reach your career goals. Because when you're at your best, nothing stands between you and your next breakthrough.