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 jnj.com 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. At Johnson & Johnson, 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 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 Sr. Clinical Research Associate- Shockwave (Reducer) 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/. Shockwave Medical 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 Sr. Clinical Research Associate (Sr. CRA) will be responsible for managing and meeting milestones of clinical studies in compliance with applicable clinical and regulatory standards and in alignment with business needs. They will be accountable for clinical study and site management activities, for coordination with cross-functional counterparts and contract research organizations (CROs) in global studies. This work is accomplished with moderate supervision and requires a motivated, self-starter who can work independently once projects are assigned. Essential Job Functions Participate in the design and execution of global studies for regulatory submissions, reimbursement and product adoption, including development of clinical study documents (protocol, case report forms, etc.), study implementation and data management. Manage study preparation, activation, enrollment, submission, maintenance and closure activities. Participate in administrative activities associated with the clinical department including procedures, training of key personnel and preparation and maintenance of objectives and budgets. Ensures appropriate oversight of clinical study and study sites by internal and external resources including, but not limited to monitoring staff, CROs and core laboratories. Manage key study investigators; foster and maintain strong relationships through direct interactions with medical advisors and clinical leaders. Negotiate contracts with hospitals, consultants, investigators, CROs, database management firms and outside suppliers. Supervise training of investigators and site staff. Evaluates clinical and adverse event data during the conduct of the study and for completion of clinical study reports and other technical documents. Ensures quality by maintaining compliance, reviewing device complaints, reviewing audit reports and implementing corrective actions. Regularly communicates with status updates to senior management and represents organization to study sites. Other duties as assigned.

Qualifications

Bachelor’s Degree in a scientific field of study with a minimum of 5 years’ experience directly supporting clinical research for medical device studies Prior experience with, or strong working knowledge of, Class III cardiovascular medical devices preferred Working knowledge of Good Clinical Practice (GCP), FDA, ISO and other applicable regulations) Knowledge of FDA and international regulations and guidelines including, but not limited to, clinical strategy, GCPs, SOPs, submissions, product launch, labeling, advertising and promotion, product vigilance and medical device reporting ACRP or SOCRA clinical research certification preferred Strong written, oral, and interpersonal communication skills including proficient knowledge of medical terminology Ability to travel up to 25% domestically and internationally High attention to detail and accuracy Computer skills (MS Office products, word processing, spreadsheets, etc.) Finance and budgeting knowledge Good prioritization and organizational skills Excellent critical thinking skills Excellent influencing and negotiation skills High energy and results-oriented individual who is mature and successful in a business environment Proactive and “can do” attitude Works effectively on large study teams and cross-functional teams Effective written, verbal and presentation skills with all levels of management and organizations Operates both as a team and independently, with adaptability to changing requirements Ability to work in a fast-paced environment, managing multiple priorities 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 ([email protected]) or contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: 临床研究和法规, 临床试验, 临床试验管理系统 (CTMS), 临床试验设计, 医疗知识, 商业行为, 实验室操作, 师徒制, 提供反馈, 沟通, 流程导向, 研究与开发, 研究伦理, 职业道德, 解决问题, 项目管理, 项目集成管理 The anticipated base pay range for this position is : $106,000.00 - $170,200.00 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are 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. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave – 80 hours in a 52-week rolling period10 days Volunteer Leave – 32 hours per calendar year Military Spouse Time-Off – 80 hours per calendar year For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits 在 Johnson & Johnson， 我们相信健康就是一切。 我们在医疗创新方面的实力使我们能够建立一个 能够预防，治疗和治愈复杂疾病的世界, 在这个世界中,治疗更智能，侵入性更低,并且 解决方案是个性化的。 凭借我们在创新医学和医疗技术方面的专业知识,我们处于独特的地位,能够在当今的全套医疗保健解决方案中进行创新,以实现未来的突破,并对人类的健康产生深远的影响。 如需了解更多信息，请访问https://www.jnj.com/。请勿出售或共享我的个人信息 限制我的个人信息的使用