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Research Associate

Cadila Pharmaceuticals
Cadila Pharmaceuticals
2+ years
Not Disclosed
10 Feb. 16, 2025
Job Description
Job Type: Full Time Education: BA/BE/B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Research Associate

Location: Dholka, India
Category: Research & Development Jobs
Company: Cadila Pharmaceuticals Ltd
Job Code: 18004113
Brand: Research & Development
Job Status: 1

Description:
• Issuing controlled documents and other approved uncontrolled usage copies of SOPs, forms, formats, logbooks, and study documents of CRO.
• Checking that correct documents are issued before distribution.
• Updating and maintaining the master document file.
• Issuing and compiling deviation forms and maintaining logs.
• Issuing and compiling change control forms and maintaining logs.
• Reviewing data submitted by the quality control department related to BA/BE study—before, during, and after completion of the study.
• Online phase monitoring of the bio-study.
• Conducting system-based audits of BA/BE/CT and BA departments at CRO.
• Verifying files and logbooks submitted for archival.
• Maintaining and updating the Quality Manual & CRO Master File.
• Reviewing validation, calibration, and maintenance of equipment and software.
• Handling sponsor audits, query resolution, and responding to sponsor queries and audit reports.
• Ensuring the updating of CRO procedures and SOPs according to current regulatory guidelines.