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Cra/Crc/ Monitoring - Clinical Trials

1-3 years
Not Disclosed
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.