Clinical Research Associate

2 weeks ago

Beijing, Beijing, China BEJ Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd Full time

About the Role:



As a Senior Clinical Monitor with BEJ Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd, you will play a vital role in the success of our global clinical monitoring team. We are seeking an experienced professional to oversee the management of clinical trials, ensuring the highest standards of quality, efficacy, and compliance.



Key Responsibilities:




  • Monitor and manage clinical sites, ensuring compliance with regulatory requirements and study protocols.
  • Liaise with vendors, investigators, and other stakeholders to ensure seamless site management.
  • Conduct pre-study and initiation visits, as well as routine monitoring and close-out visits.
  • Verify informed consent procedures and protocol requirements, ensuring patient protection and data integrity.
  • Review source documents, monitor data for missing or implausible information, and ensure audit readiness at the site level.
  • Prepare accurate and timely trip reports, ensuring efficient use of resources and adherence to SOPs and established guidelines.
  • Manage registries, undertake feasibility work, and participate in Quality Control Visits as required.
  • Recruit potential investigators, prepare EC submissions, and notify regulatory authorities as instructed by the supervisor.
  • Track and follow up on Serious Adverse Event (SAE) reporting, process production of reports, and narratives.
  • Assist with training, mentoring, and development of new employees, coordinating clinical projects as a Local Project Coordinator, and acting as a local client contact as assigned.


Requirements:




  • A minimum of 1 (one) year of clinical monitoring experience, or an equivalent combination of education and experience.
  • Ability to monitor study sites independently, according to protocol monitoring guidelines, SOP, and local regulatory guidelines.
  • Full understanding of SAE reporting, process production of reports, narratives, and follow-up of SAEs.
  • Good planning, organization, and problem-solving skills.
  • Ability to work with minimal supervision.
  • Good communication and interpersonal skills.
  • Good analytical and negotiation skills.
  • Computer competency.
  • Fluent in English, both written and verbal.
  • Valid driver's license.


About Us:



At BEJ Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd, we are committed to revolutionizing the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. We seek motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials.

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