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    Senior Clinical Research Associate

    Omega Healthcare Management Services
    2-4 years
    Not Disclosed
    Navi Mumbai
    10 Oct. 3, 2024
    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

    Job Opportunity: Senior Clinical Research Associate

    Department: Delivery
    Location: Navi Mumbai
    Closing Date: October 21, 2024
    Openings: 1
    Grade: C1C
    Reporting To: Program Manager

    Job Responsibilities

    Project and Operations Management:

    • Manage designated clinical trials and prepare trial-related documentation in accordance with protocols and Case Report Forms (CRFs).
    • Ensure the completeness and timely submission of data into data collection forms, including electronic CRFs and cancer research databases (CRDB).
    • Track completed CRFs and implement systems for rapid data entry into databases. Address queries generated during data cleaning in compliance with ICH-GCP guidelines.
    • Ensure that all trials are conducted in accordance with the approved protocol and any amendments.
    • Improve quality assurance and consistency in electronic data capture.
    • Participate in global conference calls and meetings to review the progress of ongoing clinical trials.
    • Maintain proficiency in protocol monitoring activities.
    • Verify adherence to approved protocols and GCP procedures by investigators.
    • Communicate any observations regarding protocol deviations, safety alerts, or quality issues to the sponsor.
    • Complete regulatory requirements as applicable.

    Security Responsibilities:

    • Never share passwords or sensitive information.
    • Ensure all systems are locked when not in use.
    • Avoid using unauthorized applications.
    • Do not store PHI data on the Vasta domain.

    Qualifications

    • Education: Bachelor’s or Master’s degree.
    • Experience: Minimum of 4 years in Clinical Trials Management or Protocols is preferred.
    • Knowledge: Familiarity with oncology-specific terminology and experience with EDCs such as Medidata RAVE, Oracle, or Inform is strongly preferred.
    • Skills:
      • Hands-on computer skills.
      • Strong written and verbal communication abilities.
      • Ability to multitask, work under pressure, and meet deadlines.

    If you are a dedicated professional with a passion for clinical research and possess the necessary skills and experience, we invite you to apply for this exciting opportunity!

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