ZOLL Circulation, Inc.

  • Clinical Project Coordinator

    Job Locations US-CA-San Jose
    Posted Date 2 weeks ago(10/29/2018 9:31 PM)
    Job ID
    2018-1096
    # of Openings
    1
    Category
    Clinical
  • Overview

    Summary:

    The Clinical Project Coordinator (CPC) will be responsible for providing clinical study support to assist in meeting clinical study and compliance objectives.  The CPC will conduct the study related tasks in accordance with the Good Clinical Practices (GCP) and the study protocols. The CPC provides ongoing clinical studies support as needed throughout all phases of the clinical projects. The position often requires working with clinical sites to ensure compliance with study protocols, department procedures, FDA regulations, IRB requirements and overall clinical objectives.

    Responsibilities

    Summary of Responsibilities:

    • Provide support to Clinical Affairs Team
    • Create, Organize and maintain Clinical Files (Master/Project Files, Site Files, and Patient Files) – electronic and physical files
    • Collection and tracking of Case Report Forms, Imaging and regulatory documents
    • Review and track essential study documents and site correspondence
    • Track the monitoring of Follow-Up Visits and Core lab imaging; etc.
    • Organize internal or external meetings, preparation of agendas and meeting minutes
    • May assist with the preparation and maintenance of study timelines, decision logs and status reports.
    • Download images or obtain them from sites and forward films to the Core lab
    • Assist in preparation of study binders, source documents worksheets, study tools and materials.
    • Communicate with Site Field Monitors and Site Research Coordinators to assist with obtaining patient source documentation and site regulatory documents
    • Prepare quarterly Site Payments, POs and invoicing for clinical data submitted by the sites
    • Assist with preparation of Investigators meeting materials, invitations and tracking of RSVPs
    • Assist in coordination of CEC and DSMB Meetings, including logistics, travel, etc.
    • Ensures accurate inventory of investigational devices used during clinical trials
    • Assist with preparation and assembly of presentations
    • Conduct lit searches and assemble publications
    • Perform other duties as requested.

    Qualifications

    Technical and Conceptual Skills:

    • Candidate should have demonstrated ability to work independently, interface and communicate with physicians and allied staff in the hospital environment.
    • Ability to communicate and interface with department and senior management
    • Strong initiative and positive attitude with clear and concise verbal and writing skills
    • Knowledge and ability to produce documents in Microsoft Word, Excel, PowerPoint, internet access and web-based navigation skills. Knowledge of EDC, CTMS, and Visio & MS project a plus.
    • Excellent interpersonal skills, including problem solving/decision making skills
    • High attention to detail and accuracy.
    • Ability to manage and prioritize multiple tasks and remain focused on personal objectives with minimal direction.
    • Strong interpersonal communication skills with the ability to effectively communicate across all levels.

    Education/Training/Experience Requirement:

    • BS/BA Degree in Life Sciences, Medicine, Nursing or other technical discipline or equivalent experience is preferred.
    • One to three years of project coordinator experience. Knowledge and experience with Class III medical device industry is a plus
    • Experience and knowledge of the use of investigational devices in clinical studies, in accordance with applicable FDA regulations, Good Clinical Practices, and/or International Standards is a plus

    Physical Demands:

    CRC position may require occasional travel

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