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Senior Clinical Research Associate Medical Device

2+ years
$129,000 to $138,000 per year
10 July 31, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, 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

Overview:

Provident Research Inc. is seeking a Clinical Research Associate (CRA) for an immediate opening. This remote position is dedicated to managing clinical activities across multiple study sites for a major Medical Device manufacturer. The role involves overseeing site performance, managing site visits, and ensuring strong, productive relationships with internal and external stakeholders.

Key Responsibilities:

  • Clinical Management: Oversee clinical study activities for multiple sites involved in one or several clinical projects.
  • Site Oversight: Manage performance of study sites conducting company-initiated clinical studies, including site visits, monitoring, communication, and deliverables.
  • Liaison Role: Act as the liaison between Clinical Operations and Study Site personnel for specific clinical projects.
  • Compliance: Ensure adherence to regulatory requirements and industry standards, including ICH-GCP compliance.

Required Qualifications:

  • Medical Device Experience: Previous experience in the medical device industry is mandatory.
  • Education: Bachelor’s Degree is required.
  • Regional Monitoring: Experience in regional monitoring is required.
  • Certifications: Relevant industry certifications preferred (e.g., CCRA, RAC, CDE).
  • Skills:
    • Leadership capabilities
    • Strong written and verbal communication
    • Excellent organizational skills
    • Attention to detail
    • Ability to travel regionally up to 65%

Key Activities:

  • Relationship Building: Develop and maintain relationships with investigators and site staff.
  • Patient Safety Monitoring: Review patient safety on-site, address protocol violations, and ensure the integrity of study data.
  • Project Management: Take responsibility for specific project tasks or act as the main CRA contact for individual projects.
  • Training and Inspection: Conduct on-site study-specific training (if applicable), perform site facilities inspections, and monitor compliance with ICH-GCP.

Benefits:

  • Competitive Salary: Includes medical, dental, and vision insurance.
  • Additional Benefits: Disability insurance, life insurance, 401(k) plan, paid vacation, and holidays.
  • Career Growth: Opportunity for internal promotion and diverse experiences in clinical development.

About Provident Research Inc.:

Provident Research Inc. is committed to providing employees with the tools they need to succeed. Join us and be part of a dynamic team focused on advancing clinical research and making a meaningful impact.

Apply now to be part of a growing company that values your expertise and offers a supportive work environment.