[Remote] Principal Clinical Research Associate- Shockwave (Reducer)

Note: The job is a remote job and is open to candidates in USA. Johnson & Johnson is a leading healthcare innovation company focused on improving health through advanced solutions. They are seeking a Principal Clinical Research Associate to manage global clinical studies, ensuring compliance with regulatory standards and effective project management across various vendors.ResponsibilitiesResponsible for organizing, communicating and evaluating team objectives for clinical studiesParticipates in study design and study preparation activities, as applicableDevelops and revises clinical trial documentation including clinical trial protocol development, case report form (CRF) development, IRB/Ethics submissionsParticipates or leads the process to evaluate and select potential investigators and sitesParticipates or leads the process to evaluate and select potential vendors as applicableConducts or oversees site visits as required (pre-study, initiation, interim and close-out visits) to ensure protocol compliance, accurate and thorough data collection, and appropriate study conductDevelops and revises site training tools, interprets clinical data, manages investigational sites, develops tracking tools and performs other clinical activities as needed during clinical study conductLeads clinical study teams focused on conducting clinical programs consistent with applicable regulations, guidelines, and policiesManages project timelines and vendor performance to meet departmental and corporate goalsMonitors and tracks clinical trial progress and provides status update reportsManages study budget, payment process and reconciliation of invoices for all clinical trial vendors including investigative sites when applicableOversees work produced by junior clinical team membersManages all clinical trial vendors (e.g., IRB, IVRS, central/core labs, such as angiogram, ultrasound, or central ECG)Analyzes and evaluates clinical data gathered during researchLeads, prepares and reviews project and study-related documents including: informed consent forms, investigational brochures, case report forms, monitoring plans, synopses, protocols and amendments, and other appropriate sections for studies conducted under Investigational Device Exemption (IDE) or 510(k) applicationResponsible for authoring internal documents and clinical study reports and assisting with clinical evaluation reportsDevelops and revises annual, interim, and final reports and clinical sections of Pre- or Post-Market Approval submissionsCoordinates the design, format and content of CRFs, study guides, study reference binders, and forms including participating in the EDC and IVRS specification process and UATCoordinates and manages Investigational Product including overall accountability and reconciliationResponsible for selection of CRO study staff and coordinating training including documentationLeads the review of clinical data at the CRF, data listing, and report table levelsRepresents Clinical Affairs at the Project Team level for individual studies, as appropriateIdentifies and escalates site, vendor and study related issues to supervisor, as appropriateOversees clinical and adverse event data evaluation during the conduct of the study and for completion of clinical study reports. Working knowledge of CEC and DSMBsManages training of investigators, site staff, and SWMI clinical staffOversees quality by maintaining compliance, reviewing device complaints, reviewing audit reports and implementing corrective and preventative actionsOther duties as assignedSkillsBachelor's Degree or equivalent experience in a scientific field of studyMinimum 10 years' experience directly supporting clinical research or relevant experience in medical/scientific area. Minimum 1 year in a role directly managing trials and projects, 2-3 years preferredAbility to travel 10-20% domestically and internationallyThorough knowledge of Good Clinical Practice (GCP) is requiredWorking knowledge of GCP, FDA, ISO and other applicable regulationsExperience with EDC Data Management SystemsKnowledge and experience in supporting device pre- and/or post-market clinical studies is required, including experience running IDE trialsAble to manage multiple project teamsAbility to work in a fast-paced environment while managing multiple prioritiesOperate as a team and/or independently while demonstrating flexibility to changing requirementsMust have excellent verbal and written communication skillsHigh attention to detail and accuracyBasic understanding of peripheral and coronary artery disease and therapies preferredACRP or SOCRA clinical research certification is preferredAnalytical ReasoningClinical Research and RegulationsClinical Trial DesignsClinical Trial Management Systems (CTMS)Clinical TrialsCommunicationData SavvyLaboratory OperationsOrganizingProblem SolvingProductivity PlanningProfessional EthicsProject Integration ManagementQuality Assurance (QA)Regulatory ComplianceResearch and DevelopmentResearch EthicsStandard Operating Procedure (SOP)BenefitsSubject to the terms of their respective plans, employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).This position is eligible to participate in the Companys 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 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 OverviewAt Johnson & Johnson, we believe health is everything. It was founded in 1886, and is headquartered in New Brunswick, NJ, US, with a workforce of 10001+ employees. Its website is http://www.jnj.com.Company H1B SponsorshipJohnson & Johnson has a track record of offering H1B sponsorships, with 7 in 2026, 48 in 2025, 56 in 2024, 58 in 2023, 59 in 2022, 44 in 2021, 27 in 2020. Please note that this does not guarantee sponsorship for this specific role.