Integra LifeSciences

  • Clinical Research Associate

    Vacancy ID
    2018-27466
    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

    This position is responsible for assisting in developing, planning and implementing the overall direction of clinical research projects in accordance with good scientific principles, ICH – GCP guidelines for conducting clinical studies and pertinent government regulations.

    ESSENTIAL DUTIES AND RESPONSIBILITIES 

    • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
    • Ensure compliance with ICH – GCP guidelines and all pertinent government regulations for conducting clinical studies.
    • Assist in preparation of protocols and documentation for clinical studies, entailing communication with consultants such as surgeons, radiologists and outside statisticians.
    • Assist in the IRB/EC application process, including review of informed consent / HIPAA forms for conformance to pertinent government regulations.
    • Contribute to overall data management such as case report form design, edit check review, data clarification process and evaluating and analyzing clinical data.
    • Recruit, qualify and train investigators and clinical site personnel (and laboratories, as applicable) for study participation.
    • Assist with contract and budget preparation and negotiations.
    • Coordinate activities of investigators and clinical site personnel to ensure compliance with the protocol and overall clinical objectives.
    • Coordinate the organization of study regulatory files, inventory and all related study materials and supplies.
    • Assure data integrity through proper on-site monitoring, verification of source records, documentation of protocol deviations, and completion of written reports, in accordance with department Standard Operating Procedures (SOPs).
    • Communicate with clinical sites to expedite the exchange of information and to ensure that clinical studies are kept on schedule and within budget.
    • Assist with the implementation of investigator meetings and general clinical meetings (as applicable).
    • Ensure subject safety in all areas of clinical research, following procedures to report AEs, SAEs and UADEs to clinical, regulatory and quality management.
    • Contribute to obtaining government approvals and preparing progress reports for clinical studies.
    • Promote good communication with investigational sites, within the clinical department, as well as between other Integra department members.
    • Assist R&D, marketing, and other departments in performing their duties, as appropriate.
    • Maintain awareness of current issues in clinical research by reading relevant literature and attending industry meetings and other training opportunities.
    • Assist in various projects and other duties as assigned. 

    INTERACTIONS/RELATIONSHIPS: 

    • Works with local department staff to support and achieve department objectives. 
    • Works with Global Clinical Affairs members at other locations to coordinate and streamline clinical operations worldwide.
    • Interfaces with other departments (R&D, Marketing, Sales, Legal, Regulatory, and Quality) to represent the clinical department and ensure effective inter-department communication and collaboration.

    Qualifications

    POSITION SPECIFICATIONS:

     

    Education: Bachelor’s degree, preferably in a life science or scientific related field, or RN or BSN degree, or 10+ years of recent and relevant clinical research/monitoring experience.

     

    Experience: Four years or more experience in clinical research, with a minimum of two to four years of experience in independent coordination of investigational site activity by on-site monitoring and site communications.

     

    Specific competencies: 

    • Intermediate knowledge and understanding of FDA regulations and ICH – GCP
    • Must work both independently and in a team
    • Proven track record of on-site monitoring of investigational sites and constructive site collaboration.
    • Ability to review and interpret medical records through knowledge and general application of medical terminology.
    • Excellent interpersonal, written communications, time management, and organizational skills.
    • Detail oriented with good problem-solving skills.
    • Ability to manage multiple tasks and take ownership and workflow initiative.
    • Proficient computer skills using Microsoft Office products.
    • Experience with electronic data capture (EDC) is a plus.
    • Presentation skills desired.

     

    PHYSICAL REQUIREMENTS:

     

    The physical requirements listed in this section include, but are not limited, to the motor/physical abilities and skills require of this position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position.

     

    While undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen, speak, and walk through airports etc. The employee may be required to periodically work where no special desk configurations/accommodations may be available for extended periods of time.

     

    The employee is required to go to all areas of the company and external study sites. The employee may be required to periodically lift and/or move up to 45lbs (luggage). Must be able and willing to travel (overnight) up to 50% of the time while in the position, contingent upon business needs. Ability to travel via car and/or airplane to domestic and international locations as needed.

     

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed

    Need help finding the right job?

    We can recommend jobs specifically for you! Click here to get started.