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    Cra / Crc / Monitoring - Clinical Trials

    Advity Research
    1-6 years
    3 LPA to 5 LPA
    Hyderabad
    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.

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