Senior Clinical Research Associate

4 weeks ago


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

Job Overview

As a Senior Clinical Research Associate at Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd Shanghai Branch, you will play a critical role in ensuring the integrity and quality of clinical trials. With a strong passion for scientific rigor and a commitment to excellence, our team is dedicated to transforming drug and device development for partners and patients across the globe.

Key Responsibilities

  • Monitor study sites independently according to protocol monitoring guidelines, SOPs, and local regulatory requirements.
  • Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to.
  • Monitor data for missing or implausible data and ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools.
  • Liaise with vendors, recruitment of potential investigators, and participate in Quality Control Visits (QC) as requested.
  • Track and follow up on Serious Adverse Event (SAE) reporting and assist with training, mentoring, and development of new employees.

Requirements

  • A minimum of 1 year of clinical monitoring experience, or an equivalent combination of education and experience.
  • A thorough knowledge of ICH Guidelines, local regulatory requirements, and monitoring procedures.
  • Basic understanding of the clinical trial process and ability to work with minimal supervision.
  • Good communication, analytical, and negotiation skills, as well as computer competency and fluency in English.

Compensation

The estimated salary for this position is RMB 250,000 - 300,000 per annum, depending on qualifications and experience. Benefits include comprehensive health insurance, paid annual leave, and opportunities for professional growth and development.



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