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1-2 years
Not Disclosed
10 April 16, 2025
Job Description
Job Type: Full Time Education: B.Pharm/M.Pharm 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 Research Associate (CRA)

Location:

Hyderabad, India

Experience Required:

1 – 2 years


Qualifications & Specifics

Education:

  • B. Pharmacy / M. Pharm

Preferred Skills:

  • Communication

  • Time management

  • Adaptability

  • Listening skills

  • Assertive communication

  • Technical & Scientific knowledge

  • Data integrity

  • Knowledge of SOPs

  • Regulatory awareness


Detailed Responsibilities:

  • Request and receive study-specific documents from QA

  • Compile Trial Master File (TMF) prior to the study

  • Ensure readiness of Clinical Pharmacology Units (CPUs) with the support of HK staff

  • Raise indents for required materials/supplies for the study

  • Verify protocol training completion

  • Provide ICD presentations to volunteer groups

  • Perform admission, discharge, meal distribution, and monitoring of study subjects

  • Supervise activities of CRTs, RNs, and other personnel during clinical study execution

  • Compile and review study data to ensure compliance with SOPs and protocols

  • Submit ICDs, CRFs, TMFs to QC and QA for review and closure of observations

  • Assist in archiving study documents

  • Identify SOP/protocol deviations and report them to the project in-charge

  • Ensure compliance and data integrity throughout the study process