Clinical Research Associate II

1 month ago

Pu Dong Xin Qu, China SHA Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd Shanghai Branch Full time

Overview

Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd Shanghai Branch is a leading global contract research organization with a passion for scientific rigor and decades of clinical development experience. We provide pharmaceutical, biotechnology, and medical device customers with a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas.

As a Clinical Research Associate II in our Global Clinical Development team, you will be responsible for all aspects of study site monitoring, including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaison with vendors; and other duties as assigned.

About the Role

We are seeking a highly motivated and detail-oriented individual to join our team. The ideal candidate will have at least 2 years of clinical monitoring experience and be able to monitor study sites independently according to protocol monitoring guidelines, SOP, and local regulatory guidelines. You will also have a full understanding of Serious Adverse Event (SAE) reporting and process production of reports, narratives, and follow-up of SAEs.

Responsibilities

  • Monitor study sites independently according to protocol monitoring guidelines, SOP, and local regulatory guidelines.
  • Liaise with vendors and other stakeholders to ensure smooth execution of studies.
  • Conduct pre-study and initiation visits to ensure sites are prepared for study start-up.
  • Maintain accurate and detailed records of site monitoring activities.
  • Identify and report any deviations from protocol or SOP to management.
  • Collaborate with cross-functional teams to ensure timely and successful completion of studies.

Requirements

  • Bachelor's degree or higher in a related field (e.g., life sciences, healthcare).
  • At least 2 years of clinical monitoring experience.
  • Excellent communication and interpersonal skills.
  • Ability to work independently and collaboratively as part of a team.
  • Familiarity with ICH Guidelines and local regulatory requirements.
  • Proficient in MS Office and other relevant software applications.

What We Offer

  • A competitive salary of RMB 250,000 - 300,000 per annum.
  • A comprehensive benefits package, including health insurance, retirement plan, and paid time off.
  • Ongoing training and professional development opportunities.
  • The chance to work on exciting projects and collaborate with a talented team of professionals.
  • A dynamic and supportive work environment.

How to Apply

If you are a motivated and detail-oriented individual with a passion for clinical research, please submit your resume and cover letter to us.

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