Integra LifeSciences

  • Clinical Trial Administrator

    Vacancy ID
    2018-26718
    Location
    US-NJ-Plainsboro
    Position Type
    Regular Full-Time
    Category
    Clinical Affairs
  • Overview

    Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, reconstructive and general surgery, and regenerative wound care.

     

    Integra's orthopedic products include devices and implants for foot and ankle, hand and wrist, shoulder and elbow, tendon and peripheral nerve protection and repair. Integra is a leader in neurosurgery, offering a broad portfolio of implants, devices, instruments and systems used in neurosurgery, neuromonitoring, neurotrauma, and related critical care. Integra’s Tissue Technologies is an in-patient and outpatient Regenerative product portfolio, which includes products for wound care, burns, abdominal reconstruction, and plastic & reconstructive surgery.  In the United States, Integra is a leading provider of surgical instruments to hospitals, surgery centers and alternate care sites, including physician and dental offices.


    Founded in 1989 Integra is headquartered in Plainsboro, New Jersey and has over 4,500 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol "IART."

    Responsibilities

    To perform this job successfullyan individual must be able to perform each essential duty satisfactorily:

    • Maintains and coordinates the administrative aspects of lntegra's Clinical Affairs dept. including clinical studies according to GCPs and S0Ps
    • Provides support for the preparation of clinical study reportsannual reportsinterim updates and other study or regulatory documentsas required
    • Works with study teams to prepare clinical study documentsincluding investigator meeting materials, site and training information
    • Serves aresource for clinical study sites and can triage questions/needs, as appropriate
    • Implements and maintains clinical filing systems for all shared documents and files and proactively identifies operational process improvements
    • Files and maintains study documents in the study Trial Master Files (TMFs)
    • Performs ongoing and final study-level and site-level TMF reconciliation
    • Performs data entry into designated clinical tracking systems in accordance with project requirements, including collection of information from designateclinical team membersCRO'svendorsetc.
    • Assists with the processing of both vendor and site payments
    • Assists with gathering and tracking clinical trial accruals
    • Provides accurate progress reports on assigned tasks and projects
    • Contributes to wider organizational goals and/or activities as assigned
    • Ensures study compliance by understanding and applying all relevant SOPs
    • Performs various administrative duties such as travel arrangements, expense reporting, meeting minutes and other administrative duties for the department as needed.
    • Works with department staff to support and achieve department objectives.
    • Works with Global Clinical Affairs members at other locations to coordinate and streamline clinical operations worldwide.

    Qualifications

    The requirements listed below are representative of the knowledge, skill and/or ability required for this position: 

    • Minimum of a Bachelor's degree in a relevant scientific and/or financial discipline
    • 2 years relevant (clinical research and/or finance) experience
    • Strong written and verbal communication skills
    • Demonstrated organizational skills
    • Ability to work independently in a fast-paced team environment
    • Computer software: Microsoft Word, Excel, PowerPointProject, Visio
    • Experience using a document management system preferred
    • Basic knowledge and understanding of pharmaceutical regulatory requirements, including FDA and ICH guidelines would be a plus.

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