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  • Posted: Jun 6, 2017
    Deadline: Not specified
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    inVentiv Health is a global professional services organization designed to help the biopharmaceutical industry accelerate the delivery of much-needed therapies to market. Our combined Clinical Research Organization (CRO) and Contract Commercial Organization (CCO) offer a differentiated suite of services, processes and integrated solutions that improve client...
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    Clinical Research Associate II/Senior

    Job description

    Job ID 15580

    Position Overview

    As a key member of our Clinical Monitoring team you will be responsible for all clinical monitoring activities following study guidelines, SOPs, and applicable regulations. Travel will be across the country with a maximum expectation of eight days on site per month, supported by a local Line Manager and with excellent opportunity for career development inVentiv Health really can offer you a CRA role with a difference.

    Responsibilities

    • Perform site visits and monitor activities in accordance with protocol, GCP/ICH Guidelines, and other applicable regulatory requirements
    • Mentor CRAs on monitoring, internal procedures, and query resolution
    • Use expertise and judgement to identify and resolve complex site issues and deficiencies in documentation, communication, and the need for additional training
    • Assess and ensure overall integrity of study and adherence to guidelines, protocols, and regulations
    • Evaluate overall performance of site and site staff
    • Ensure compliance and understanding of study requirements by site staff
    • Provide recommendations regarding site-specific actions and use judgment and expertise to assess ability of site staff
    • Interpret data to identify protocol deviations or major risks to data integrity
    • Understand project scope, budgets, and timelines and be able to provide input and manage project objectives to meet timelines
    • Act as a liaison between the company and study site personnel and be able to respond to site concerns and questions
    • Review and verify case report forms and other clinical data for completeness and accuracy
    • Monitor patient safety and identify and address any protocol deviations and make appropriate recommendations
    • Generate queries and manage resolutions with site staff
    • Maintain project tracking systems as required
    • Participate in the identification and selection of investigators and clinical sites
    • Assist in the development of study specific monitoring procedures and guidelines
    • Mentor junior staff on training, guidelines, and processes
    • Complete assigned training programs and apply learning
    • Maintain working knowledge of GCP/ICH Guidelines as well as all applicable regulations

    Requirements

    • Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
    • Prior clinical monitoring experience
    • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
    • Strong organizational skills
    • Must demonstrate good computer skills
    • Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade

    Compensation & Benefits

    Overview Competitive remuneration package with excellent benefits

    Commitment to your development and training, with the opportunity to progress your career within a market leading and innovative organization

    Opportunity to work within a successful and rewarding environment

    Method of Application

    Interested and qualified? Go to inVentiv Health Commercial on careers2.hiredesk.net to apply

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