• Clinical Research Specialist

    Position Location US-CA-Rancho Santa Margarita
  • _________________________________________________________________________________

    Applied-Medical-Logo-w-Tag_H_Teal_cropped

    Applied Medical is a new generation medical device company with a proven business model and commitment to innovation that has fueled our rapid business growth and expansion. Applied Medical has been developing and manufacturing advanced surgical technologies for over30 years, and has earned a strong reputation in healthcare.  Our dedication to delivering the highest quality products and unique business positioning, provides our team members with the unique ability to contribute in a larger capacity than is possible in typical positions.

    Position Description

    As a Clinical Research Specialist you will be responsible for working within the framework of a team and performing the following activities:

     

    • Develop strategies and methods to support ongoing post-market surveillance data collection and analysis from various sources, including medical device databases, published literature and internal data
    • Lead the team with systematic literature reviews for the generation of Clinical Evaluation reports and Post-Market Surveillance reports
    • Support the team in preparation of protocols in support of clinical evaluations
    • Determine criteria and weighted methods to analyze existing published data
    • Screen titles, abstracts and full text of publications from the literature search for clinical data on assigned medical devices in accordance with the inclusion/exclusion criteria from the protocol
    • Work with team members to interpret clinical data from medical and scientific literature during the screening and data extraction steps of the systematic literature review process
    • Work with the team to define roles and develop processes for post-market surveillance
    • Manage active clinical studies and external physician-initiated research requests, and provide input on study design, setup and outcome measures of new requests
    • Determine the need for additional clinical evidence and work with clinicians to conduct research
    • Review product support materials to ensure that literature citations are correct and the level of evidence is identified
    • Manage library of published data relevant to Applied Medical’s products
    • Provide analysis of clinical data relevant to Applied’s product lines
    • Design and drive the execution of pre-market and post-market clinical trials globally, and collaborate on the dissemination of the resulting evidence to internal and external stakeholders
    • Perform statistical analysis to ensure that studies are appropriately designed and powered correctly
    • Perform statistical analysis to verify the strength of published studies regarding Applied Medical products

    Position Requirements

    This position requires the following skills and attributes:

    • BS/BA/RN and/or MS/MSN degree in science or a health related field
    • 3-5 years of experience working with medical devices or healthcare in a clinical research management role
    • Effective written and oral communication skills
    • Ability to collaborate in a team environment
    • Ability to formulate reports and present findings
    • Ability to execute tasks quickly and with meticulous accuracy and consistency
    • Proficiency in using Microsoft Office programs, including, but not limited to, Word, Excel, PowerPoint, Outlook
    • Knowledge of research methodology (including clinical investigation design and biostatistics)
    • Knowledge of information management
    • Knowledge of GCP and FDA regulations
    • Knowledge of clinical research regulations, guidelines and compliance including IRB
    • Understanding and experience with statistics
    • Experience with medical writing
    • Experience conducting systematic literature searches
    • Ability to understand and interpret statistical results of clinical studies and understand good data management practices

    Preferred

    The following skills and attributes are preferred: 

    • Certified Clinical Research Associate (CCRA) credential
    • Understanding of MDD requirements
    • Demonstrated knowledge and experience in clinical research, quality regulatory compliance and adverse event reporting
    • Experience within the medical device industry and knowledge of clinical evaluation reporting and regulatory requirements
    • Skilled in narrative or systematic literature reviews (e.g. PRISMA, Cochrane)

    Benefits

    • Training and mentorship with ongoing learning and development courses
    • On-campus wellness activities
    • Comprehensive medical and dental coverage
    • Education reimbursement program
    • 401(k) program with employer match
    • Generous vacation accrual and paid holiday schedule

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