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Cra / Crc / Monitoring - Clinical Trials

Advity Research
ADVITY Research
1-6 years
3 LPA to 5 LPA
5 Aug. 7, 2024
Job Description
Job Type: Full Time Education: BSC, MSC, B Pharma, M Pharma, Pharma D 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: CRA / CRC / Monitoring - Clinical Trials

Location: Tier I & Tier II cities

Experience Required: 1 to 3 years

Employment Type: Full Time

Department: Clinical Trials

Education Qualification: Any Science Graduate

Job Type: At Clinical Trials site

Job Description:

  • Trial Monitoring: Monitor the trial throughout its duration, including regular visits to study centers.
  • Resource Planning: Plan and ensure the availability of study-specific requirements, including resources and consumables.
  • Document Management: Ensure the availability of all essential documents prior to study initiation for allocated studies.
  • Pharmacy Coordination: Coordinate for retention, sending back, or destruction of materials at the pharmacy.
  • TMF Supervision: Review and supervise TMF (Trial Master File) filing throughout the study duration.
  • Compliance Supervision: Ensure all study activities are carried out in compliance with in-house SOPs and the approved protocol.
  • IMP Management: Ensure adequate quantity of Investigational Medicinal Products (IMPs) to conduct the clinical trial and manage IMP supplies, accountability, and retention at the study center.
  • CRF Design: Design data collection forms, known as Case Report Forms (CRFs).
  • Informed Consent Process: Discuss and document the process of obtaining informed consent forms.
  • Consent Verification: Verify the documentation of the informed consent process for each study subject.
  • Data Verification: Verify that data entered on CRFs is consistent with patient clinical notes (Source Data/Document Verification - SDV).
  • CRF Collection: Collect completed CRFs from hospitals and general practices.
  • Visit Reporting: Write visit reports.
  • Study Closure: Close down study centers upon completion of the trial.
  • Archiving: Archive study documentation and correspondence.