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  • Posted: Sep 23, 2020
    Deadline: Not specified
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  • IQVIA, formerly Quintiles and IMS Health, Inc.,is an American multinational company serving the combined industries of health information technology and clinical research. It is a provider of biopharmaceutical development and commercial outsourcing services, focused primarily on Phase I-IV clinical trials and associated laboratory and analytical services,...
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    Site ID Svcs Specialist 2

    Job Overview

    Manage and lead activities associated with Feasibility and/or Site Identification for regional and/or country projects and/or programs.

    Essential Functions

    • Manage assigned opportunities/projects/programs for country or region and adhere to timelines and budget.
    • Ensure the site list for assigned studies includes an adequate number of appropriate investigators in accordance with the needs of the sponsor and specifications of the protocol.
    • Collect and analyze country/regional Feasibility and/or Site Identification information to meet timelines of each study.
    • Attend kick off meetings to understand study requirements include investigator profile, protocol, process specifics and timelines.
    • Raise questions and make suggestions based on SID SOPs and Work Instructions.
    • Distribute, track, negotiate and review the Confidential Disclosure Agreements (CDAs) for Feasibility and/or Site Identification with input from the study team, management and Legal when appropriate.
    • Distribute, track and review Site Questionnaires  for Feasibility and/or Site Information Forms or Site Qualification Questionnaires for SID .
    • Ensure completeness, site capability and suitability for the study. For SID review SIF and/or SQQ vs the guidance document and approve for SSV or select appropriate sites.
    • Manage investigator database entry and quality, ensuring complete investigator and site information is captured and monitor for duplicate entries.
    • Maintain and update company information repositories and databases.

    Qualifications

    3 years clinical research experience. Equivalent combination of education, training and experience

    At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way

    go to method of application »

    Associate Clinical Research Associate

    Job description

    • Perform site selection (if applicable), initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.
    • If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis. Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.
    • Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
    • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
    • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
    • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
    • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
    • Build awareness of features and opportunities of study to site.
    • Collaborate and liaise with study team members for project execution support as appropriate.

    At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way.

    Method of Application

    Use the link(s) below to apply on company website.

     

    Note: Never pay for any training, certificate, assessment, or testing to the recruiter.

  • Send your application

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