Endologix, Inc

  • Sr. Clinical Research Associate

    Job ID
  • 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 Senior Clinical Research Associate will directly supervise all study management activities for the Company’s global clinical efforts. This is a team focused role working directly with other clinical and regulatory professionals; including working with CROs (Contract Research Organizations) involved in the Company’s clinical efforts, and integrating those efforts with other departments within the Company. Regularly interacts with regulatory agencies, physicians and other scientists involved in clinical research, and regularly participates as a key resource in the Company’s product development and commercialization efforts.



    To perform this job successfully, an individual must be able to perform each essential job task satisfactorily. The tasks listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.


    • Project coordination, planning and logistics, including budget and timelines
    • Verifying that all research staff, facilities and investigational products have adequate qualifications and resources and these remain adequate throughout the trial
    • Responsible for the safety and proper conduct throughout the trial
    • Verifying that the investigator follows the approved protocol and all GCP (Good Clinical Practice) procedures
    • Verifying that source data/documents and other trial records are accurate, complete, and maintained
    • Adverse events, concomitant medications, and inter current illnesses are reported in accordance with the protocol on the CRFs (Case Report Forms).
    • Communicating deviations from the protocol, SOPs (Standard Operating Procedures), GCP, and the applicable regulatory requirements to the investigator
    • Assist and/or manage activities and interactions with CROs and/or vendors.
    • Maintains all relevant documentation and communications as part of study files.
    • Coordinates clinical site monitoring activities, and may participate in site monitoring associated with initiation, interim, close out, and audit visits as required.
    • Adhere and assist with clinical operations and project specific quality documents (for example: SOPs, work plans/practices, training guides).
    • Review study data and resolution of queries, compile data for data review, create tables and graphs under appropriate guidance, and assist with the preparation and review of clinical study reports.



    • Perform other duties as assigned by supervisor.
    • Ability to travel up to 30%, based on project needs.


    • Strong Multitasking and Project Management Skills - ability to coordinate or manage multiple projects across multiple centers.
    • Detail Oriented - unparalleled attention to detail and organization
    • Strong communication skills - communicates effectively in both written and interpersonal formats with all levels of the organization.
    • Consulting Skills – ability to work and partner effectively with others within the company and outside of the company.
    • Professional Conduct & Demeanor – projects a professional and polished demeanor in all situations.
    • Excellent Problem Solving Skills – ability to understand issues and communicate effectively with clients and team.


    Minimum Education:


    • Bachelor’s degree in a clinical, scientific, or related field required.
    • Advanced degree (Masters, PhD or MD) preferred.

    Minimum Experience:



    • A minimum of 4+ years of CRA experience in the Medical Device Industry. (Masters may substitute for one year of experience, PhD or MD may substitute for two years of experience).
    • Experience in Cardiovascular, Vascular, and/or Class-III Devices is highly preferred.
    • Experience as a Study Lead and/or Study Manager is highly preferred.
    • Experience with electronic data capture (EDC) systems is preferred.
    • Strong working knowledge of medical/scientific terminology and knowledge of FDA (Food & Drug Administration) regulations and GCP guidelines is required.
    • Advanced skills in Microsoft Office Suite and standard computer programs required.



    Specific Skills, Knowledge & Behaviors




    Supervisor Core Competencies:

    Leading Change: Develops and implements strategies and approaches for leading and managing organizational transformation at individual , functional, and enterprise levels, and influences change where needed

    Inspiring the Workforce: A compelling storyteller, motivates and engages employees at individual and group levels towards results

    Selecting & Developing Talent: Assesses, selects, coaches, mentors, provides constructive feedback, empowers and develops the workforce at individual and group levels

    Strategic thinking: Creates the vision and direction, assesses priorities, understands , analyzes, and acts upon drivers of business and operational success at a departmental, functional, and/or enterprise level

    Global & systems thinking: Understands and embraces global nuances, leads across functions and geographies, builds alignment across diverse groups , and looks at the company holistically

    External Industry Leadership & Knowledge: Connects with and influences health care and/or functional industry regulatory and government organizations, and understands external industry factors that impact the company and products

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

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

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

     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.




    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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