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Senior Field Clinical Research Associate

Company: Endologix, Inc.
Location: Irvine
Posted on: June 14, 2019

Job Description:

*

SENIOR FIELD CLINICAL RESEARCH ASSOCIATE

Job ID

2019-2068

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 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.

RESPONSIBILITIES

* Performs as a study lead or study manager for an IDE trial.

* Ensures study execution (both internally and externally) is in accordance with the study protocol, Instructions for Use, FDA regulations, GCP, and Standard Operating Procedures.

* Executing on all delegated tasks associated with clinical trial execution, including the day-to-day communications and functional activities with investigational sites.

* Study coordinating, planning, and logistics, to ensure project milestones are met.

* Identifies, resolves, and/or escalates issues that have a significant impact to the study execution.

* Provides updates to Cross Functional teams on a regular basis

* Contributes to the development of protocol, Informed Consent Form, Case Report Forms, and any additional study documents.

* Continuing oversight of all research staff, facilities and investigational products have adequate qualifications and resources and these remain adequate throughout the trial.

* Ensures compliance to the Monitoring Plan.

* Verifying that source data/documents and other trial records are accurate, complete, and maintained

* 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).

* Monitors and reconciles the electronic data capture system

* 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.

QUALIFICATIONS

*

* Perform other duties as assigned by supervisor.

* Ability to travel up to 30%, based on project needs.



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

* Strong working knowledge of medical/scientific terminology and knowledge of FDA (Food & Drug Administration) regulations, specific to 21 CFR 812, and GCP guidelines is required.

* Advanced skills in Microsoft Office Suite and standard computer programs required.

Experience with Medical Devices is preferred.



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.

Endologix, Inc. is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.

Keywords: Endologix, Inc., Irvine , Senior Field Clinical Research Associate, Healthcare , Irvine, California

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