Sr. Clinical Research Associate- Shockwave (Reducer)

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.comAs 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 FunctionR&D OperationsJob Sub FunctionClinical Trial Project ManagementJob CategoryProfessionalAll Job Posting Locations:New Brighton, Minnesota, United States of America, Santa Clara, California, United States of AmericaJob DescriptionJohnson & 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 OverviewThe 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 FunctionsParticipate 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.QualificationsBachelor’s Degree in a scientific field of study with a minimum of 5 years’ experience directly supporting clinical research for medical device studiesPrior experience with, or strong working knowledge of, Class III cardiovascular medical devices preferredWorking 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 reportingACRP or SOCRA clinical research certification preferredStrong written, oral, and interpersonal communication skills including proficient knowledge of medical terminologyAbility to travel up to 25% domestically and internationallyHigh attention to detail and accuracyComputer skills (MS Office products, word processing, spreadsheets, etc.)Finance and budgeting knowledgeGood prioritization and organizational skillsExcellent critical thinking skillsExcellent influencing and negotiation skillsHigh energy and results-oriented individual who is mature and successful in a business environmentProactive and “can do” attitudeWorks effectively on large study teams and cross-functional teamsEffective written, verbal and presentation skills with all levels of management and organizationsOperates both as a team and independently, with adaptability to changing requirementsAbility to work in a fast-paced environment, managing multiple prioritiesJohnson & 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.Required SkillsPreferred Skills:Business Behavior, Clinical Research and Regulations, Clinical Trial Designs, Clinical Trial Management Systems (CTMS), Clinical Trials, Communication, Give Feedback, Laboratory Operations, Medical Knowledge, Mentorship, Problem Solving, Process Oriented, Professional Ethics, Project Integration Management, Project Management, Research and Development, Research EthicsThe anticipated base pay range for this position is :$106,000.00 - $170,200.00Additional Description For Pay TransparencySubject 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.BenefitsSubject 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 yearSick 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 yearHoliday pay, including Floating Holidays –13 days per calendar yearWork, Personal and Family Time - up to 40 hours per calendar yearParental Leave – 480 hours within one year of the birth/adoption/foster care of a childBereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar yearCaregiver Leave – 80 hours in a 52-week rolling period10 daysVolunteer Leave – 32 hours per calendar yearMilitary Spouse Time-Off – 80 hours per calendar yearFor additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits