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Senior Clinical Research Associate Medical Device

5+ years
$129,000 to $138,000 per year
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!