Sr CRA | South Korea
Inc Research, LLC
134, ro,Teheran,Seoul, KOR,Korea Republic of
24 일 전


Why Syneos Health? Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most.

Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator.

You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past.

Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-

  • deliver and outperform. A career with Syneos Health means your everyday work improves patients’ lives around the world.Purpose of Job : Senior Clinical Research Associate performs routine site visits to ensure that the rights and well being of human subjects are protected;
  • the reported trial data are accurate, complete, and verifiable from source documents; and that the conduct of the trial is in accordance with the currently approved protocol / amendment(s), SOPs, ICH / GCP Guidelines and other applicable regulatory requirements.

    In doing this, the Clinical Research Associate II represents InVentiv Health Clinical and the sponsor to site personnel and colleagues with professionalism and integrity.Major Responsibilities

  • Perform routine site visits, including pre-study, initiation, interim, and closeout visits. Performs responsibilities with minimal support from management.
  • Visits to include monitoring of proper informed consent procedures, compliance with protocol, ICH / GCP Guidelines and other applicable regulatory requirements, and assurance of good site performance.

    This is accomplished by detailed review of subject records, essential documents, investigational product disposition and accountability, site personnel and procedures.

  • Manage assigned sites by regular contacts to ensure site compliance, adequate enrollment, and understanding of study requirements.
  • Report to InVentiv Health Clinical project team, client, and site personnel any findings noted at monitoring visits. This is accomplished by completion of monitoring reports and follow-
  • up letters within the project-specific timelines. Significant issues noted must be reported to appropriate personnel immediately.

  • Maintain eClinical or alternative project tracking system of subject and site information.
  • Participate in company-required training programs.
  • Perform necessary administrative functions (e.g., tracking of expense reports, time and attendance).
  • Perform other duties as assigned.
  • Qualifications

  • Bachelor’s level degree in life sciences, pharmacy, nursing or RN preferred
  • Knowledge of ICH / GCP Guidelines and other applicable regulatory requirements
  • Ability to work independently in a fast-paced environment
  • Strong communication, interpersonal, and organizational skills
  • Must demonstrate good computer skills
  • Position requires 30% - 70% travel is expected depending on business needsDisclaimer : Tasks, duties, and responsibilities as listed in this job description are not exhaustive.
  • The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and / or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.

    The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.

    Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills / experiences for jobs are expressed in brief terms.

    Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

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