Principal Clinical Research Associate- Shockwave (Reducer)

At reputed company, we reputed company health is everything. Our strength in healthcare innovation empowers us to build a world where reputed company 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 reputed company of healthcare solutions today to deliver the breakthroughs of reputed company, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, reputed company is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At reputed company, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

R&D Operations

Job Sub Function:

Clinical Trial Project Management

Job Category:

Professional

reputed company Job Posting Locations:

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

Job Description

reputed company is hiring for a Principal Clinical Research Associate- Shockwave (Reducer) to join reputed company. The position is FULLY REMOTE and can sit reputed company in the US.

At reputed company, we reputed company health is everything. Our strength in healthcare innovation empowers us to build a world where reputed company 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 reputed company of healthcare solutions today to deliver the breakthroughs of reputed company, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

reputed company is a fast-growing medical device company focused on revolutionizing the treatment of advanced cardiovascular disease. With the innovative Shockwave Reducer System, we are creating new opportunities for patients and physicians in the treatment of refractory angina – long-lasting, debilitating chest pain that cannot be controlled by traditional medicine or surgical procedures and affects millions of people world-wide.

Position Overview

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

Essential Job Functions

• Responsible for organizing, communicating and evaluating team objectives for clinical studies.
• Participates in study design and study preparation activities, as applicable.
• Develops and revises 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 reputed company-out visits) to ensure protocol compliance, accurate and thorough data collection, and appropriate study conduct.
• Develops and revises 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 reputed company and provides status update reports.
• Manages study budget, payment process and reconciliation of invoices for reputed company clinical trial vendors including investigative sites reputed company applicable.
• Oversees work produced by junior clinical team members.
• Manages reputed company clinical trial vendors (e.g., IRB, IVRS, central/core labs, such as angiogram, ultrasound, or central ECG).
• Analyzes and evaluates clinical data gathered during research.
• Leads, prepares and reviews project and study-reputed company 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 in