PRAHS

  • Independent Drug Monitor Coordinator

    Job Locations - | US-Remote
    Posted Date 6 days ago(6 days ago)
    ID
    2018-49139
  • Overview

    Works in partnership with the scientific, business, operational, clinical and technology areas to support the execution of global clinical trials in the areas of unblinded drug management and clinical supply inventory for phase I-IV clinical studies

    Responsibilities

    • Monitor global clinical supply inventory for both Interactive Voice Response Systems (IVRS) and traditional studies.
    • Resolve issues involving distribution of clinical supplies, including US & International shipments, temperature excursions, etc.
    • Monitor study specific milestone dates and adjust drug distribution plan accordingly.
    • Manage clinical supply complaints received from investigative sites and/or subsidiaries.
    • Address supply replacement requests.
    • Monitor expiry dating for clinical study supplies.
    • Interact with other departments, as needed, to resolve any issues involving clinical supply inventory and distribution.
    • Lead study teams in management of the development of pharmacy related materials (e.g., forms and manuals) and system set-up (e.g., IVRS and EDC).
    • Provide input into the clinical monitoring plan as required.
    • Resolve and document urgent/critical unblinded and pharmacy related issues and investigate trends.
    • Act as the main point of contact for resolution of any ad-hoc questions associated with clinical supplies and unblinded drug management.
    • Provide input to refine the Clinical Supplies process in alignment with stakeholder needs and in compliance with systems and strategies.
    • Work proactively to increase stakeholder’s global awareness of the Clinical Supplies process.
    • Contribute to ensuring optimum utilization of resources and compliance with project deadlines.
    • Review monitoring visit reports as designated (initiation, periodic & close-out) (defined % per study requirements).
    • Identify, document and escalate major/critical issues to the clinical trial team.
    • Evaluate metric data to identify process improvements.
    • Assist in database locks in reviewing unblinded queries (as needed).
    • Provide updates to clinical trial team on pharmacy-related and compliance issues in a blinded fashion.
    • Ensure that all tasks meet Sponsor and PRAHS expectations, and are delivered in accordance with the contract, trial protocol, ICH/GCP and applicable SOPs.
    • Identify and promotes best practices.
    • Proactively identify, communicate, and lead organizational dialogue related to clinical trial solutions to minimize timelines and reduce costs.
    • Liaise with clinical trial personnel to determine trial support required, inclusive of testing, timelines and implementation plan.
    • Supports activities associated with ensuring appropriate compliance (Health Care Compliance, Privacy, IT, Legal, Regulatory, Internet, etc.) for various types of web-based initiatives such as mobile applications and websites.
    • Partner with clinical and operations staff to provide support and consulting services to pharmaceutical company clients.
    • This is not an exhaustive, comprehensive listing of job functions and tasks. Other duties may be performed as assigned.

    Qualifications

    • Experience in clinical monitoring and or project management and/or logistics is mandatory.
    • Knowledge of ICH/GCP and local regulatory authority regulations regarding drug development.
    • Read, write and speak English; fluent in host country language required.
    • Minimum of two (2) years relevant work experience in a pharmaceutical, biotech and Clinical Research Organization (CRO) environment.
    • Strong understanding and experience with information systems.
    • Demonstrate ability to escalate issues appropriately.
    • Demonstrates working knowledge of Microsoft Office applications, Clinical Trial Management Systems, IVRS/IWRS and other study management systems.

     

    • Bachelor’s degree
    • Knowledge of databases and/or project management systems is also a plus

     

    • To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.

       

    • PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

     





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