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

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Johnson & Johnson is hiring for a Sr. Principal Clinical Research Associate - 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 Sr. Principal Clinical Research Associate (Sr. Principal CRA) is responsible for the day-to-day management of a global clinical study. The Sr. Principal CRA will be accountable for project management activities, oversight of multiple vendors and for conducting a global clinical study in compliance with applicable clinical and regulatory standards and in alignment with business needs. The Sr. Principal CRA is a subject matter expert in clinical research and this work is accomplished with minimal oversight, requires frequent contact with internal and external customers, and is critical to the success of the business.

Essential Job Functions

• Responsible for the day-to-day management of domestic and global clinical studies for pre- and post-market products. Responsible for organizing, communicating and evaluating team objectives for clinical studies

• Participates in study design and study preparation activities

• Development of clinical trial documentation including clinical trial protocol development, case report form (CRF) development, IRB/Ethics submissions

• Participates or leads the process to evaluate and select potential investigators and sites

• Participates or leads the process to evaluate and select potential vendors as applicable

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

• Develops site training tools, interprets clinical data, manages investigational sites, develops tracking tools and performs other clinical activities as needed during clinical study conduct

• Leads clinical study teams focused on conducting clinical programs consistent with applicable regulations, guidelines, and policies.

• Manages project timelines and vendor performance to meet departmental and corporate goals

• Monitors and tracks clinical trial progress and provides status update reports

• Manages study budget, payment process and reconciliation of invoices for all clinical trial vendors including investigative sites when applicable

• Oversees work produced by junior clinical team members

• Manages all clinical trial vendors (e.g., IVRS, central labs, IRB, and central ECG)

• Analyzes and evaluates clinical data gathered during research

• Leads, prepares and reviews project and study-related documents including: informed consent forms, investigational brochures, case report forms, monitoring plans, synopses, protocols and amendments, and other appropriate sections for studies conducted under Investigational Device Exemption (IDE) or 510(k) application.

• Responsible for authoring internal documents, clinical study reports or clinical evaluation reports

• Develops and revises annual, interim, and final reports and clinical sections of Pre- or Post-Market Approval submissions

• Coordinates the design, format and content of CRFs, study guides, study reference binders, and forms including participating in the EDC and IVRS specification process and UAT

• Coordinates and manages Investigational Product including overall accountability and reconciliation

• Responsible for selection of CRO study staff and coordinating training including documentation

• Leads the review of clinical data at the CRF, data listing, and report table levels

• Represents Clinical Affairs at the Project Team level for individual studies, as appropriate

• Identifies and escalates site, vendor and study related issues to supervisor, as appropriate

• Oversees clinical and adverse event data evaluation during the conduct of the study and for completion of clinical study reports. Working knowledge of CEC and DSMBs.

• Manages training of investigators, site staff, and SWMI clinical staff.

• Oversees quality by maintaining compliance, reviewing device complaints, reviewing audit reports and implementing corrective actions.

• Other duties as assigned.

Requirements

• Bachelor’s Degree in a scientific field of study

• Minimum 12 years’ experience directly supporting clinical research or relevant experience in medical/scientific area. 5+ years in a clinical management role, managing trials and projects

• Ability to travel 10-20% domestically and internationally

• Thorough knowledge of Good Clinical Practice (GCP), FDA, ISO and other applicable regulations.

• Experience with EDC Data Management Systems

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

• Knowledge and experience in supporting device pre- and/or post-market clinical studies is required including experience running IDE trials

• ACRP or SOCRA clinical research certification preferred

• Able to manage multiple project teams

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

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

• Must have excellent verbal and written communication skills

• High attention to detail and accuracy

Pay Transparency:

• The anticipated salary range for this position is US: $115, 000 - $197, 800 / Bay Area: $141, 000 - $227, 700

• 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:

Additional Description for Pay Transparency: