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    Senior Clinical Research Associate Medical Device Remote

    Provident Research Inc
    5+ years
    $129,000 to $138,000 per year
    Remote, USA
    10 Aug. 20, 2024
    Job Description
    Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any Life Science Graduate 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)

    About the Role:

    Provident Research Inc. is seeking an experienced Clinical Research Associate (CRA) to join our dedicated Functional Source (embed) team. This role will be working closely with one of our major clients, a leading Medical Device manufacturer, to manage clinical activities across multiple study sites. As a key member of the clinical study team, you will serve as the liaison between Clinical Operations and Study Site personnel, ensuring the smooth execution of company-initiated clinical studies. This position is open due to recent expansion, with interviews currently being scheduled for immediate placement.

    Key Responsibilities:

    • Site Management & Monitoring:

      • Oversee clinical study activities at multiple sites across single or multiple clinical projects.
      • Conduct site visits, monitor study progress, and ensure compliance with protocol and regulatory requirements.
      • Build and maintain strong, productive relationships with investigators, site staff, and internal colleagues.

    • Communication & Coordination:

      • Serve as the primary liaison between Clinical Operations and Study Site personnel for assigned projects.
      • Facilitate communication and deliverables between study sites and the clinical study team.
      • Address and resolve any protocol violations, missing Serious Adverse Events (SAEs), Adverse Events (AEs), or Concomitant Medications (ConMed).

    • Compliance & Training:

      • Ensure site compliance with ICH-GCP guidelines and other relevant regulations.
      • Conduct on-site study-specific training as needed and perform site facilities inspections.

    • Project Involvement:

      • Take responsibility for specific tasks on projects or act as the main CRA contact on individual projects.
      • Monitor patient safety on-site and ensure all data is accurately recorded and reported.

    Qualifications:

    • Education:

      • Bachelor’s degree required.

    • Experience:

      • Previous experience in regional monitoring, particularly within the Medical Device industry, is mandatory.
      • Strong understanding and application of clinical research regulations and standards.
      • Relevant industry certifications preferred (e.g., CCRA, RAC, CDE).

    • Skills:

      • Proven leadership abilities and strong organizational skills.
      • Excellent written and verbal communication skills.
      • High attention to detail and the ability to manage multiple tasks.
      • Ability to travel regionally up to 65%.

    Benefits:

    This position offers a competitive salary and the opportunity to explore various aspects of the clinical development industry. Provident Research Inc. is committed to the growth and advancement of our employees, offering a clear career pathway with opportunities for promotion. Additional benefits include:

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

    About Provident Research Inc.:

    At Provident Research Inc., we are dedicated to providing our employees with the tools they need to succeed. Join our team and be part of a movement that values innovation, growth, and collaboration.

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