
location_onI 694, New Brighton, Ramsey County, Minnesota, 55112, United States
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.
Shockwave Medical is a fast-growing medical device company within our MedTech portfolio, 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—a condition affecting millions worldwide that cannot be controlled by traditional medicine or surgical procedures.
To support the growing Shockwave Reducer business, we are establishing a dedicated facility in New Brighton, MN. We are actively seeking motivated individuals who bring relevant industry experience and are enthusiastic about learning and growing within the Reducer business.
The Clinical Trials Assistant serves as a vital support pillar for the clinical study team, ensuring the smooth execution of clinical trials. This role is central to maintaining study integrity through general oversight, project communications, and administrative management. You will act as a central contact for the clinical team, handling site correspondence, internal and vendor updates, and managing team agendas and meeting minutes.
Your day-to-day impact involves maintaining and updating databases for clinical activity tracking, managing study payments and invoice processing, and overseeing the shipment of study supplies to ensure investigator sites are adequately equipped. You will also play a key role in document management by tracking incoming and outgoing clinical and regulatory documents, reviewing Trial Master Files (TMFs) for accuracy, and assisting with the preparation of Study Coordinator and Investigator Meetings. Success in this role requires the ability to operate effectively within a fast-paced environment, managing multiple priorities while adhering to ICH Good Clinical Practice (GCP) guidelines and company Standard Operating Procedures.
Johnson & 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 at ra-employeehealthsup@its.jnj.com or contact AskGS to be directed to your accommodation resource.
As guided by Our Credo, Johnson & Johnson 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. We respect the diversity and dignity of our employees and recognize their merit.
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.
Skills: Microsoft Word, Excel, Powerpoint, GCP, Ich Good Clinical Practice, Fda Regulations, Clinical Trial Designs, Clinical Research And Regulations, Clinical Operations, Regulatory Compliance.
Education: High School diploma required; Associate or bachelor's degree in biological sciences, health care management, life sciences research, or other relevant area of study preferred; Associate or bachelor's degree in biological sciences, health care management, life sciences research, or other relevant area of study preferred.
Work model: On-site
I 694, New Brighton, Ramsey County, Minnesota, 55112, United States
New Brighton, Minnesota
Associate or bachelor's degree in biological sciences, health care management, life sciences research, or other relevant area of study. Experience directly supporting clinical research or relevant experience in medical/scientific area. Working knowledge of GCP and FDA regulations.
Shockwave Medical, headquartered in Santa Clara, California, operates within the medical equipment manufacturing industry to address advanced cardiovascular disease. The company specializes in developing technology designed to target calcified plaque within arteries, drawing on three decades of safety and efficacy data originally established in kidney stone treatment. Its core offering includes the Intravascular Lithotripsy family of catheters, which deliver localized lithotripsy directly to the site of cardiovascular calcium. This approach facilitates gentle balloon dilatation of calcified, stenotic arteries that are otherwise difficult to treat.
The technology functions by utilizing sonic pressure waves that preferentially impact hard tissue to disrupt calcium deposits while leaving surrounding soft tissue undisturbed. Following this disruption, an integrated balloon catheter performs dilatation at low pressure, effectively restoring blood flow through the treated vessel. The company maintains an online presence at www.ShockwaveMedical.com and communicates updates via Twitter under the handle @ShockwaveIVL. This operational model focuses on providing interventional solutions for complex vascular conditions without making claims regarding market leadership or specific client outcomes beyond the described mechanism of action.
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