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 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 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 #J-18808-Ljbffr Johnson & Johnson MedTech

Job Tags

Similar Jobs