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  • Posted: Dec 6, 2024
    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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    Sr CRA 1

    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.

    go to method of application »

    CTA 1

    Job Overview

    • Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery.

    Essential Functions

    • Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines.
    • Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
    • Assist with periodic review of study files for completeness.
    • Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
    • Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
    • Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
    • May accompany CRAs on site visits to assist with clinical monitoring duties upon completion of required training.

    Qualifications

    • High School Diploma or equivalent  Req
    • 3 years administrative support experience.
    • Equivalent combination of education, training and experience.
    • Computer skills including working knowledge of Microsoft Word, Excel and PowerPoint.
    • Written and verbal communication skills including good command of English language.
    • Effective time management and organizational skills.
    • Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
    • Awareness of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines as provided in company training.
    • Knowledge of applicable protocol requirements as provided in company training.

    Method of Application

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

     

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