Firoj Hossain Gharami

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Clinical Research Coordinator & Data Manager at Netaji Subhas Chandra Bose Cance

Kolkata, India

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His background

  • Today
    2014

    CRC

  • Today
    2010
    2006

    Clinical Research Coordinator

    Netaji Subhash Chandra Bose Cancer Research Institute

    KEY RESPONSIBLILITIES
    •Reviewing the protocol and other materials like Informed Consent Forms.
    •Looking at subject eligibility requirements and determining if those subjects would be available in the site.
    •Assessing the ability to meet study timelines in light of other site commitments and overall feasibility.
    •Assessing the resources necessary to do the study, including people, physical space, materials etc.
    •Training the other staffs involved in the trial.
    •Setting up and organizing study files.
    •Creating and reviewing study-specific source documents and other study-related materials.
    •Disseminating information about the study to others in the institution.
    •Arranging the submission of necessary documents to the IEC.
    •Collecting the documents needed to initiate the study and sending them to the sponsor.
    •Attending the investigator meeting.
    •Clarifying any necessary items with the sponsor.
    •Assisting in writing consents.
    •Interacting with the sponsor on Informed Consent wording issues.
    •Presenting the Informed Consent Form to potential subjects, discussing the consent and the study with them, and answering questions.
    •Obtaining all the necessary signatures and dates on the Informed Consent Forms.
    •Documenting, distributing and filing signed Informed Consent Forms appropriately.
    •Ensuring that all amended consent forms are appropriately implemented and signed.
    •Contacting and screening potential subjects for the study.
    •Recruiting subjects.
    •Scheduling subject and sponsor visits.
    •Ensuring that all study procedures are done in each and every subject visit.
    •Ensuring that all the necessary data are gathered and recorded in the appropriate source documents and the case report forms.
    •Reviewing source documents and case report forms for completeness, correctness and logical sense.
    •Working with sponsor monitors (CRAs) during monitoring visits.
    •Resolving data queries through paper CRF & e CRF.
    •Ensuring that study documents are complete, current and filed correctly.
    •Maintaining study supplies accountability and reordering study supplies as nessassary.
    •Managing payments to study subjects.
    •Completing study closeout activities at the end of the study.
    •Coordinating with other departments (laboratory, pharmacy etc.) as necessary.
    •Maintaining regular communications with sponsors and/or CROs, IECs and other parts of the institution.
    •Ensuring adherence to ICH-GCP in conducting all the trial activities.
    •Ensuring safety and well-being of all study subjects throughout the trial.

    RESPOSIBILITIES

    •Helping to recruit new studies.
    •Professionally representing the site to all people / organizations in the best possible light.
    •Assessing feasibility of new sites.

    # ACHIVEMENT

    ►Certificate of Investigator Meets (IM) of Clinical Good Practice training program
    Conducting clinical trial with Sanofi- Aventis dated June 2008.
    ► Certificate of GCP (Good Clinical Practice) by Eli- Lilly Company on 29th
    March 2009.
    ►Certificate of Investigator Meets (IM) of Clinical Good Practice training program
    conducting clinical trial by Bristol Myers Squibb Pvt ltd in Mumbai, 03rd & 4th
    April 09.
    ►Certificate of Investigator Meets (IM) of Clinical Good Practice training program
    conducting clinical trial Onconova (Max Neeman International at Mumbai on dated
    11th & 12th December 2009.
    ►Certificate of Investigator Meets (IM) of Clinical Good Practice training program
    conducting clinical trial Actavis (Lotus Labs. Pvt Ltd at Bangalore on dated 19th &
    20th December 2009.
    ► Certificate of Completion TAO ON- SITE Training by BMS (Bristol Myers
    Squibb Pvt ltd).
    ►Certificate of completion Monitoring Responsibilities at by BMS (Bristol Myers
    Squibb Company).
    ►Certificate of completion of Clinical Good Practice (GCP) of the training
    Program conducting clinical trial with Bristol Myers Squibb Pvt Ltd.
    ►Certificate of completion of Informed Consent Procedure of the training
    program conducting clinical tria

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His languages

  • English
    ****Bilingual

    About him

    To work in a challenging and dynamic working environment and to add value to the organization, which I represent and serve, and also to myself, while concurrently upgrading attitude, skills and knowledge.

    His activity on Viadeo

    Recent contacts
    Stanley Wee
    Hemant ZAVERI

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