Principal Clinical Research Associate – Shockwave, Reducer

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🏄 California, Minnesota – Remote

🏄 California – Remote ❄️ Minnesota – Remote

💵 $125k - $201.3k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🔬 Research Analyst

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Johnson & Johnson

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1886

⚕️ Healthcare Insurance

💊 Pharmaceuticals

🧬 Biotechnology

Healthcare Insurance • Pharmaceuticals • Biotechnology

Johnson & Johnson is a multinational corporation focused on innovating across multiple sectors of healthcare and medicine. With a commitment to redefining healthcare, the company merges science and technology to address complex diseases through its divisions in innovative medicine and medical technology. Its areas of focus include oncology, immunology, neuroscience, and specialty ophthalmology, as well as interventional solutions and orthopaedics. J&J is dedicated to advancing global health equity and environmental sustainability while fostering innovation, diversity, and inclusion in the workplace. The company strives to provide solutions that connect health and care for providers, patients, and communities worldwide.

📋 Description

• Responsible for organizing, communicating and evaluating team objectives for clinical studies • Participates in study design and study preparation activities, as applicable • Develops and revises clinical trial documentation including clinical trial protocol development, case report form (CRF) development, IRB/Ethics submissions • Participates or leads the process to evaluate and select potential investigators and sites • Participates or leads the process to evaluate and select potential vendors as applicable • Conducts 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 conduct • Develops and revises site training tools, interprets clinical data, manages investigational sites, develops tracking tools and performs other clinical activities as needed during clinical study conduct • Leads clinical study teams focused on conducting clinical programs consistent with applicable regulations, guidelines, and policies • Manages project timelines and vendor performance to meet departmental and corporate goals • Monitors and tracks clinical trial progress and provides status update reports • Manages study budget, payment process and reconciliation of invoices for all clinical trial vendors including investigative sites when applicable • Oversees work produced by junior clinical team members • Manages 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 research • Leads, 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) application • Responsible for authoring internal documents and clinical study reports and assisting with clinical evaluation reports • Develops and revises annual, interim, and final reports and clinical sections of Pre- or Post-Market Approval submissions • Coordinates the design, format and content of CRFs, study guides, study reference binders, and forms including participating in the EDC and IVRS specification process and UAT • Coordinates and manages Investigational Product including overall accountability and reconciliation • Responsible for selection of CRO study staff and coordinating training including documentation • Leads the review of clinical data at the CRF, data listing, and report table levels • Represents Clinical Affairs at the Project Team level for individual studies, as appropriate • Identifies and escalates site, vendor and study related issues to supervisor, as appropriate • Oversees clinical and adverse event data evaluation during the conduct of the study and for completion of clinical study reports.

🎯 Requirements

• Bachelor’s Degree or equivalent experience in a scientific field of study • Minimum 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 preferred • Ability to travel 10-20% domestically and internationally • Thorough knowledge of Good Clinical Practice (GCP) is required • Working knowledge of GCP, FDA, ISO and other applicable regulations • Experience with EDC Data Management Systems • Basic understanding of peripheral and coronary artery disease and therapies preferred • Knowledge and experience in supporting device pre- and/or post-market clinical studies is required, including experience running IDE trials • ACRP or SOCRA clinical research certification is preferred • Able to manage multiple project teams • Must have excellent verbal and written communication skills • High attention to detail and accuracy

🏖️ Benefits

• Retirement plans (pension) • Savings plan (401(k)) • 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 period • Volunteer Leave – 32 hours per calendar year • Military Spouse Time-Off – 80 hours per calendar year