Clinical Research Associate II

1 month ago

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

Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd Shanghai Branch is seeking a highly motivated and detail-oriented Clinical Research Associate II to join our team. As a Clinical Research Associate II, you will be responsible for monitoring clinical sites, maintaining study files, conducting pre-study and initiation visits, and liaising with vendors.

Key Responsibilities
  1. Monitor study sites independently according to protocol monitoring guidelines, SOP, and local regulatory guidelines.
  2. Ensure the integrity of data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review.
  3. Monitor data for missing or implausible data.
  4. Ensure the resources of the Sponsor and Company are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines.
  5. Ensure audit readiness at the site level.
  6. Travel, including air travel, may be required and is an essential function of the job.
  7. Prepare accurate and timely trip reports.
  8. Undertake feasibility work when requested.
  9. Participate in and follow up on Quality Control Visits (QC) when requested.
  10. Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings, and other tasks as instructed by supervisor.
  11. Track and follow up on Serious Adverse Event (SAE) reporting, process production of reports, narratives, and follow up of SAE.
  12. Independently perform CRF review; query generation and resolution against established data review guidelines on Company or client data management systems as assigned by management.
  13. Assist with training of new employees, e.g., co-monitoring.
  14. Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned.
  15. Perform other duties as assigned by management.
Requirements
  • At minimum of 1(One) year of clinical monitoring experience is preferred, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job can be substituted.
  • Ability to monitor study sites independently according to protocol monitoring guidelines, SOP, and local regulatory guidelines.
  • Have a full understanding of the Serious Adverse Event (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 local office language and in English, both written and verbal.
  • Works efficiently and effectively in a matrix environment.
Education/Qualifications/Certifications and Licenses
  • University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate.
  • Thorough knowledge of ICH Guidelines and understanding of local regulatory requirements.
  • Thorough knowledge of monitoring procedures.
  • Basic understanding of the clinical trial process.
  • Valid Driver's License.
About Fortrea

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.

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