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Cra / Crc / Monitoring - Clinical Trials

1-3 years
Not Disclosed
10 Dec. 23, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Here’s a structured version of your job posting:


Department

Clinical Trials

Education Qualification

Any Science Graduate

Job Type

On-Site at Clinical Trials Site


Job Description

Key Responsibilities

  1. Study Monitoring

    • Regularly visit study centers to monitor trials throughout their duration.
    • Ensure all study activities comply with in-house SOPs and the approved protocol.
  2. Planning and Resource Management

    • Plan and ensure the availability of study-specific requirements, including resources and consumables.
    • Coordinate retention, return, or destruction of materials at the pharmacy.
  3. Documentation and Filing

    • Ensure all essential documents are prepared and available before study initiation.
    • Supervise Trial Master File (TMF) filing throughout the study.
    • Archive study documentation and correspondence after study completion.
  4. Investigational Medicinal Products (IMP)

    • Ensure adequate quantities of IMPs are available for the clinical trial.
    • Oversee IMP supplies, accountability, and retention at study centers.
  5. Data Collection and Verification

    • Design data collection forms (Case Record Forms - CRFs).
    • Verify consistency between data entered on CRFs and patient clinical notes (Source Data Verification).
    • Collect completed CRFs from hospitals and general practices.
  6. Informed Consent Process

    • Discuss and oversee the process of obtaining informed consent forms (ICFs) and ensure proper documentation.
    • Verify that informed consent is documented appropriately for each subject.
  7. Reporting and Close-Out Activities

    • Write detailed visit reports summarizing activities and findings.
    • Close down study centers upon trial completion.

This role is essential for ensuring the successful execution and compliance of clinical trials. It offers an opportunity to work on the ground and contribute directly to advancing clinical research.

Would you like to include additional information such as desired experience or application instructions?