Endologix, Inc

  • Principal Clinical Research Associate

    Job ID
    2018-1820
    Location
    US-CA-Irvine
    Category
    Clinical
  • Overview

    Endologix develops and manufactures the latest innovations in endovascular aneurysm repair and sealing. We are a fast-moving, high energy organization. Employees are offered development opportunities and new responsibilities that might have taken them significantly more time in other organizations. Our commitment is to promise the development and refinement of skills while providing competitive compensation and benefits.

     

     

    The Principal Clinical Research Associate will design, plan and conduct all aspects of clinical research trials, with minimal oversight, by effectively coordinating the activities of study coordinators, investigators, Endologix staff, and by ensuring compliance with study protocols, FDA and International regulations, IRB and/or Ethics committee’s requirements and overall clinical objectives.

    Responsibilities

    • Under the direction of the Sr. Manager, Clinical Affairs, implement clinical research projects with a minimum of direct oversight

    • Oversee patient screening and enrollment at assigned clinical study sites.

    • Monitor ongoing compliance to study protocols.

    • Work with investigators to quickly and effectively resolve discrepancies.

    • Review source documentation, case report forms, and data reports for accuracy and ensure the timely submission of such documentation.

    • Perform site training to ensure compliance to the Investigation Plan.

    • Develop materials for clinical training sessions.

    • Coordinate meetings with site coordinators and investigators.

    • Identify and prepare written reports as required.

    • Ensure accurate inventory of investigative devices.

    • Regularly recognize problems and recommend corrective and preventive action.

    • Supports development of the Design and Process FMEA.

    • Identifies hazards and mitigating risk associated with identified hazards in Design and Process FMEA and determining severity of the harms associated with identified hazards.

    • Evaluates product history data based on customer complaint records, results of controlled investigations and published literature for the device or similar devices, if applicable.

    • Attend relevant scientific and/or medical meetings.

    • 30 to 50% travel.

    • Distributes work to an operational team, allowing for work-load and skill level. Keeps track of action items as they are generated.

    • Be a key point of contact for study specific questions from both internal (e.g., site monitors, clinical services specialists, and other departments) and external (e.g., site personnel, vendors) customers.

    • Facilitate communication across departments and elevate site and study issues as appropriate.
    • Keep the senior manager apprised of trial progress and critical issues at all times
    • Provides recommendations of ways to improve department methodologies.

    • Reviews clinical data through monitoring reports and data listings in order to monitor overall clinical data quality and identify and resolve potential study or site issues as appropriate.

    • Generates summaries of data, both operational and outcomes, to management when requested.

    • Writes reports (Clinical Study Reports and APRs), including review of reports and assembly of appendices; database lock activities; deviations repository; ensuring that the study close out activities are completed; ensuring study documentation is properly archived when the study is considered completed

    • Writes a clinical study protocol draft from scratch, with appropriate input from other departments. Knows who and when to collaborate on different areas.

    • Collects and tracks study specific data and produces clinical status, trend, and metric reports, including financial, to assist the senior manager in proactive study management and contingency planning

      Perform other duties as assigned by supervisor

    Qualifications

     

    Education:

    • Minimum of seven (7) years clinical trial experience with medical devices is preferred.

    • Bachelor's degree or higher in Life Sciences/Engineering/Public Health/Business, or other equivalent years of experience.

    • Master’s degree in a scientific field will substitute for one (1) year of experience. Doctorate will substitute for two (2) years of experience. Bachelor’s degree in Computer Science, Biostatistics, Biomedical Engineering or related fields. Higher education is preferred MS or Ph.D.

     

    Experience

    • Knowledge of FDA regulatory requirements related to the conduct of clinical studies.
    • Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors
    • Exercise good judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
    • Normally receives no instructions on routine work, general instructions on new assignments.

     

     

    Specific Skills, Knowledge & Behaviors

     

     

     

    Core Competencies:

     

    Interpersonal Effectiveness: Actively seeks to understand perspectives and interpersonal needs and expectations of others at all levels, builds self awareness, flexes personal style appropriately, and works through conflicts constructively and appropriately

    Communication: Effectively uses all mediums of communication as appropriate, presents well to groups, actively listens, and continuously identifies opportunities to build communication skills

     Collaboration & Teamwork: Actively works together with formal and informal team members to build relationships and achieve team goals

    Prioritization: Effectively prioritizes work to ensure timely completion of work within scope

    Global & Systems Thinking: Continuously seeks to learn about and embrace global nuances, works across functions and geographies, seeks to align with diverse groups, and seeks to understand interdependencies and impacts of actions across functions and the company

    Technical Expertise: Continuously builds functional and technical expertise, and pro-actively applies that technical expertise in progressively broader scope

    Continuous Improvement: Learns and uses best practices tools and methodologies to assess, identify, and executes on opportunities to improve; Focus on learning and building new capabilities into self

    Problem Solving & Problem Prevention: Learns and uses strong problem solving methodologies and tools, focuses on root cause analysis, and shows orientation towards problem prevention

    Accountability: Focuses on results, takes initiative without direction, takes ownership for all work within scope, builds relationships and works across departments, functions, or areas of responsibility

     

    Equipment Use & Abilities Required:

     

     

    Equipment Use:  Copy machines, fax machines, calculators and personal computers and computer terminals.

    Language Skills:  Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, legal documents or governmental regulations.  Ability to write reports, business correspondence, and procedure manuals.  Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. 

    Mathematical Skills: Ability to work with mathematical concepts such as probability and statistical inference.  Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

     

    WORK ENVIRONMENT & PHYSICAL DEMANDS OF THE JOB:

     

    The noise level in the work environment is usually quiet. While performing the duties of this job, the employee is regularly required to sit; use hands and fingers; talk or hear. The employee is occasionally required to reach with hands and arms and to move within and between the buildings.  A computer terminal is used to access, input, and retrieve data. The employee must occasionally lift and/or move 20-50 pounds. Specific vision abilities required by this job include close vision.

     

    Endologix, Inc. is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity, gender expression, genetic information, marital status, veteran status or any other characteristic protected by applicable federal, state, or local law.

                                                

    If you are a qualified individual with a disability or a disabled veteran, you have the right to request an accommodation if you are unable or limited in your ability to use or access our career center as a result of your disability. To request an accommodation, contact a Human Resources Representative at Endologix Global Headquarters at 949-595-7200 or Endologix Santa Rosa Facility at 707-543-8800

     

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