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Clinical Research Associate Ii - Shockwave Reducer

2+ years
$74,000 – $119,600
10 April 29, 2025
Job Description
Job Type: Full Time Remote Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Job Title:
Clinical Research Associate II – Shockwave Reducer (Remote)

Function:
R&D Operations

Sub Function:
Clinical Trial Project Management

Category:
Analyst, Clinical Trial Project Management (P4 – E24)

Location:
Remote (Eligible locations: Santa Clara, CA / New Brighton, MN / Anywhere in the United States)

Date Posted:
April 17, 2025

Requisition Number:
R-010184

Work Pattern:
Fully Remote

Closing Date:
May 02, 2025 (May be extended)

Description:
Johnson & Johnson is hiring a Clinical Research Associate II (CRA II) for the Shockwave Reducer portfolio, focusing on Intravascular Lithotripsy (IVL) for treating calcified cardiovascular disease. This is a fully remote role available anywhere in the U.S. The CRA II will support global clinical trials for the Reducer device and gain experience in managing clinical trial processes. This position collaborates with investigators, site staff, vendors, and internal teams to ensure regulatory and protocol compliance.

Key Responsibilities:

  • Assist with clinical study design and setup

  • Conduct site visits (pre-study, initiation, interim, and close-out)

  • Review monitoring reports and support site training

  • Develop and maintain study documentation, CRFs, and guidelines

  • Review informed consent forms for GCP compliance and accuracy

  • Coordinate regulatory documents and site communications

  • Author internal reports and portions of clinical study documents

  • Manage site payments and invoice tracking

  • Support SOP and work instruction development

Requirements:

  • Bachelor’s degree in science or healthcare

  • Minimum 2 years of experience in clinical research within the medical device industry (Sponsor role)

  • Strong communication, organizational, and detail-orientation skills

  • Working knowledge of GCP, FDA, ISO, and applicable regulations

  • Familiarity with peripheral and coronary artery disease is a plus

  • Ability to travel 10–20% domestically/internationally

  • EDC system experience required

  • ACRP or SOCRA certification preferred

Compensation & Benefits:

  • Base Salary Range:
    $74,000 – $119,600 (U.S.); $86,000 – $138,000 (Bay Area)

  • Annual performance bonus eligibility

  • Benefits include: medical, dental, vision, life & disability insurance, legal services, pension, 401(k)

  • Time Off:

    • Vacation: Up to 120 hours/year

    • Sick Leave: 40–56 hours/year

    • Holidays: Up to 13 days/year

    • Personal/Family Time: Up to 40 hours/year

  • Long-term incentive plan eligibility

Equal Opportunity Employer:
Johnson & Johnson encourages applications from veterans and individuals with disabilities. Accommodations are available upon request.