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Clinical Trial Assistant

Lupin
Lupin
0-3 years
Not Disclosed
10 Jan. 15, 2025
Job Description
Job Type: Full Time Education: M.Pharma/B.Sc/B.Pharma 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

Job Title: Clinical Trial Assistant
Company: Lupin
Location: Pune
Experience Level: 0 - 3 years
Compensation: Not disclosed
Employment Type: Full-time, Temporary/Contractual

Job Description:
Lupin is looking for a Clinical Trial Assistant to support ongoing clinical research studies. This role will involve a variety of tasks, including preparing and sending clinical trial documents to sites, coordinating with study sites, assisting Clinical Research Associates (CRAs), maintaining study trackers, reviewing invoices, and providing in-house support for studies. The ideal candidate will work closely with the study team to ensure the smooth execution of clinical trials.

Key Responsibilities:

  • Prepare and send EC (Ethics Committee) and SIV (Site Initiation Visit) dossiers to study sites.
  • Dispatch clinical trial supplies as required.
  • Coordinate with study sites for ongoing studies.
  • Assist CRAs with updating in-house files and perform quality reviews.
  • Maintain and update study trackers (documents, finance, study equipment).
  • Review and process invoices from study sites.
  • Assist with meeting minutes and training coordination.
  • Support other activities as required by the study and organization.

Preferred Qualifications:

  • Thorough understanding of ICH-GCP (International Council for Harmonisation - Good Clinical Practice).
  • Good communication skills and the ability to work under pressure.
  • Ability to multitask and work independently with attention to detail.
  • 2-3 years of experience in Pharma/Biotech/CROs in Clinical Research is preferred.
  • Education: B.Sc, B.Pharma, M.Pharma.

Skills:

  • ICH-GCP knowledge
  • Good communication
  • Multi-tasking
  • Independent work
  • Attention to detail

Perks and Benefits:

  • Full-time position with contractual employment options.
  • Opportunity to gain hands-on experience in clinical research.

Company Overview:
Lupin is a global pharmaceutical company committed to improving health and quality of life worldwide through the development of innovative and affordable medications.