[Remote] Sr. Clinical Research Associate- Shockwave (Reducer)

Note: The job is a remote job and is open to candidates in USA. Shockwave Medical is a fast-growing medical device company focused on revolutionizing the treatment of advanced cardiovascular disease. The Sr. Clinical Research Associate will be responsible for managing and meeting milestones of clinical studies in compliance with applicable clinical and regulatory standards while coordinating with cross-functional counterparts and contract research organizations.ResponsibilitiesParticipate 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 managementManage study preparation, activation, enrollment, submission, maintenance and closure activitiesParticipate in administrative activities associated with the clinical department including procedures, training of key personnel and preparation and maintenance of objectives and budgetsEnsures appropriate oversight of clinical study and study sites by internal and external resources including, but not limited to monitoring staff, CROs and core laboratoriesManage key study investigators; foster and maintain strong relationships through direct interactions with medical advisors and clinical leadersNegotiate contracts with hospitals, consultants, investigators, CROs, database management firms and outside suppliersSupervise training of investigators and site staffEvaluates clinical and adverse event data during the conduct of the study and for completion of clinical study reports and other technical documentsEnsures quality by maintaining compliance, reviewing device complaints, reviewing audit reports and implementing corrective actionsRegularly communicates with status updates to senior management and represents organization to study sitesOther duties as assignedSkillsBachelor'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 regulationsKnowledge 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 reportingStrong 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 prioritiesACRP or SOCRA clinical research certification preferredBusiness BehaviorClinical Research and RegulationsClinical Trial DesignsClinical Trial Management Systems (CTMS)Clinical TrialsCommunicationGive FeedbackLaboratory OperationsMedical KnowledgeMentorshipProblem SolvingProcess OrientedProfessional EthicsProject Integration ManagementProject ManagementResearch and DevelopmentResearch EthicsBenefitsSubject 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.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 yearCompany OverviewShockwave Medical is a medical device company that develops Intravascular Lithotripsy (IVL) for treating calcified coronary diseases. It is a sub-organization of Johnson & Johnson Medtech. It was founded in 2009, and is headquartered in Fremont, California, USA, with a workforce of 1001-5000 employees. Its website is http://shockwavemedical.com.