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    Cra/Crc/ Monitoring - Clinical Trials

    Advity Research
    1-3 years
    Not Disclosed
    Remote
    10 Feb. 10, 2025
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

    Department

    Clinical Trials

    Education Qualification

    Any Science Graduate

    Job type

    At Clinical Trials site

    Job Description

    • Monitoring the trial throughout its duration, which involves visiting the study centres on a regular basis.
    • Planning and ensuring the availability of allocated study specific requirements including resources, consumables etc.
    • Ensuring the availability of all essential documents (prior to study initiation) for allocated studies
    • Coordination for retention, sending back or destruction at the Pharmacy
    • Review and supervision of TMF filing across the study duration.
    • Supervision and ensuring of all study activities are to be carried out in compliance with in-house SOPs and approved protocol.
    • Responsible for ensuring adequate quantity of IMPs to conduct clinical trial.
    • Responsible to ensure IMP supplies, accountability and retention quantity at study centre.
    • Designing data collection forms, known as case record forms (CRFs).
    • Discussion on the process of obtaining informed consent form and documentation.
    • Verifying the documentation of the informed consent process for each study subject.
    • Verifying that data entered on to the CRFs is consistent with patient clinical notes, known as Source Data/Document Verification (SDV).
    • Collecting completed CRFs from hospitals and general practices.
    • Writing visit reports.
    • Closing down study centres on completion of the trial.
    • Archiving study documentation and correspondence.

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