CRA II | Taiwan
Syneos Health
Taiwan- TWN--
7天前

Description

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.

Responsibilities

The Clinical Research Associate II will perform clinical monitoring activities following study guidelines, SOPs, and applicable regulations.

This position is responsible for ensuring the overall integrity of assigned studies through the use of independent judgment to assess adherence to study protocol and regulations.

  • Perform site visits and monitor activities in accordance with protocol, GCP / ICH Guidelines, and other applicable regulatory requirements.
  • Assess and ensure overall integrity of study and adherence to guidelines, protocols, and regulations.
  • Evaluate overall performance of site and site staff.
  • Ensure compliance and understanding of study requirements by site contacts.
  • Apply judgment and knowledge to independently resolve site issues
  • Interpret data to identify protocol deviations or major risks to data integrity.
  • Provide recommendations regarding site-specific actions and use judgment and experience to assess ability of site staff
  • Understand project scope, budgets, and timelines and be able to provide input and manage project objectives to meet timelines.
  • Act as a liaison between the company and study site personnel and be able to respond to site concerns and questions.
  • Review and verify case report forms and other clinical data for completeness and accuracy.
  • Monitor patient safety, identify and address any protocol deviations.
  • Generate queries and manage resolutions with site personnel.
  • Participate in the identification and selection of investigators and clinical sites.
  • Maintain project tracking systems as required.
  • Work with junior staff on training, guidelines, and processes.
  • Complete assigned training programs and apply learning.
  • Maintain working knowledge of GCP / ICH Guidelines as well as all applicable regulations.
  • Disclaimer :

    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.

    Requirements

  • Bachelor's degree or RN in a related field or equivalent combination of education, training and experience
  • Two to three years prior clinical monitoring experience
  • Knowledge of Good Clinical Practice (GCP) / ICH Guidelines and other applicable regulatory requirements
  • Strong organizational skills
  • Must demonstrate good computer skills.
  • Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
  • Ability to travel
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