Clinical Research Associate I, FSPx, Sr.

2 weeks ago


Dalian, Liaoning, China DAL Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd, Dalian Branch Full time

As a renowned global contract research organization (CRO), DAL Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd, Dalian Branch provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas.

Job Responsibilities:

The Senior Clinical Research Associate, FSPx, 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; liaise with vendors; and other duties, as assigned.

Key Responsibilities:

  • Ensure the study staff who will conduct the protocol have received the proper material and instructions to safety enter patients into the study.
  • Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
  • Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review.
  • Monitor data for missing or implausible data.
  • Ensure the resources of the Sponsor and Labcorp Drug Development are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Labcorp Drug Development travel policy.
  • Ensure audit readiness at the site level.

Requirements:

  • Two (2) years of clinical monitoring experience.
  • Thorough knowledge of regulatory requirements.
  • Thorough understanding of the drug development process.
  • Fluent in local office language and in English, both written and verbal.

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need.



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