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    Senior Clinical Research Associate Medical Device

    Provident Research Inc
    5+ years
    $129,000 to $138,000 per year
    Remote, USA
    10 Sept. 3, 2024
    Job Description
    Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any LifeScience 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

    Clinical Research Associate - Remote (West Coast USA)

    Company: Provident Research Inc.
    Location: Remote (West Coast USA)
    Client: Major Medical Device Manufacturer

    Position Overview:

    Provident Research Inc. is seeking an experienced Clinical Research Associate (CRA) for a remote position based on the West Coast. This role involves managing clinical activities across multiple study sites for a major medical device manufacturer, with a focus on maintaining strong, productive relationships within the organization. Immediate openings are available due to expansion.

    Key Responsibilities:

    • Manage clinical study activities across multiple sites for single or multiple clinical projects.
    • Oversee the performance of assigned study sites conducting company-initiated clinical studies.
    • Conduct site visits, monitoring, and ensure the timely completion of deliverables for assigned study sites.
    • Act as a key member of the clinical study team and serve as the liaison between Clinical Operations and study site personnel.
    • Build and maintain strong relationships with investigators and site staff.
    • Monitor patient safety on-site, including reviewing for missing Serious Adverse Events (SAEs), Adverse Events (AEs), and concomitant medications (ConMed), and address protocol violations.
    • Take responsibility for specific tasks within projects or act as the primary CRA contact for individual projects.
    • Perform site-specific training and site facilities inspections as needed.
    • Ensure compliance with ICH-GCP guidelines and applicable regulations.

    Qualifications:

    • Bachelor’s Degree required.
    • Mandatory experience in medical device clinical research.
    • Previous regional monitoring experience required.
    • Understanding and application of regulations and standards in clinical research.
    • Relevant industry certifications preferred (e.g., CCRA, RAC, CDE).

    Skills and Competencies:

    • Strong leadership and organizational skills.
    • Excellent written and verbal communication abilities.
    • High attention to detail.
    • Ability to travel regionally up to 65%.

    Benefits:

    • Competitive salary
    • Medical, Dental, and Vision Insurance
    • Disability Insurance
    • Life Insurance
    • 401(k) Plan
    • Paid Vacation and Holidays
    • Education Opportunities

    About Provident Research Inc.:

    Provident Research Inc. is committed to equipping our employees with the tools needed to thrive in their roles. Join us and become part of a dynamic and supportive team dedicated to excellence in clinical research.

    Application Process:

    Interviews are being scheduled now to fill these immediate openings. Apply today to be considered for this exciting opportunity!

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