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Cra 2

1+ years
Not Disclosed
10 Jan. 8, 2025
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, 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

Title: Clinical Research Associate (CRA)

Job Overview:
As a Clinical Research Associate (CRA) at IQVIA, you will perform site monitoring and management activities to ensure study compliance with protocols, applicable regulations, guidelines, and sponsor requirements. You will be responsible for site visits, managing recruitment, monitoring study data, and ensuring the quality and integrity of the study conduct.

Essential Functions:

  • Conduct site monitoring visits (selection, initiation, monitoring, and close-out) in compliance with GCP and ICH guidelines.
  • Collaborate with sites to drive and track subject recruitment plans to meet project needs.
  • Provide training on study protocols to assigned sites and maintain ongoing communication to manage expectations and address issues.
  • Evaluate site practices for protocol adherence and escalate quality issues as needed.
  • Track the progress of assigned studies, including regulatory submissions, recruitment, CRF completion, and data query resolution.
  • Ensure site documents are filed correctly in the Trial Master File (TMF) and Investigator's Site File (ISF), in compliance with GCP and local regulations.
  • Document site management activities, monitoring visit findings, and action plans through regular reports and follow-up letters.
  • Collaborate with study team members to support project execution.
  • Manage site financials and recruitment plans as required.

Qualifications:

  • Bachelor’s Degree in a scientific discipline or healthcare-related field preferred.
  • Minimum of 1 year of on-site monitoring experience.
  • Knowledge of clinical research regulatory requirements (GCP, ICH).
  • Proficient in Microsoft Word, Excel, PowerPoint, and use of mobile devices.
  • Strong written and verbal communication skills.
  • Excellent organizational, time management, and problem-solving abilities.
  • Ability to build and maintain effective working relationships with colleagues, clients, and study sites.

About IQVIA:
IQVIA is a global leader in clinical research services, commercial insights, and healthcare intelligence. We connect data, technology, and expertise to accelerate the development and commercialization of innovative treatments. Learn more at IQVIA Careers.