Senior Clinical Research Associate

PSI CRO AG · Shanghai, China · full-time · On site · August 28, 2026

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Posted August 28, 2026 · Read from PSI CRO
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Job Description

As a Senior CRA at PSI you will enjoy a variety of monitoring tasks and work on clinical studies in different therapeutic indications, maintaining the highest quality standards in the industry.

You will:

  • Communication:
  • Act as main liaison between project team, sponsor and trial sites;
  • Maintain good relationships with site staff.
  • Site Monitoring:
  • Perform full‑cycle site visits (selection, initiation, routine, close‑out);
  • Drive enrollment and timeline delivery;
  • Handle AE/deviation communications, SDV, data queries and trial risk management;
  • Manage investigational products and trial supplies;
  • Ensure site‑level quality, data integrity and ISF/TMF compliance;
  • Support audit preparation, finding resolution and CAPA activities.
  • Site Management:
  • Coordinate document and supply logistics among sites, labs and warehouse;
  • Support site contracting & payment; provide investigator training and newsletter inputs.
  • Trial Records:
  • Maintain trial tracking systems;
  • Assist regulatory/ethics submissions, IP‑RED collection and TMF reconciliation;
  • Review translated trial records upon manager approval.
  • Lead Monitoring:
  • Oversee site feasibility and start‑up; review regulatory/IP‑RED documents;
  • Track enrollment/timelines and implement corrective‑preventive actions;
  • Review monitoring reports, drive query resolution and manage regional clinical supplies;
  • Act as key contact for monitors and project leadership;
  • Lead country‑level project calls, supervise audit activities, report project status, deliver investigator‑meeting presentations and mentor junior monitors.
  • Other departmental assignments, as necessary.

Qualifications

  • Bachelor's or above degree in Life Sciences, Pharmacy, RN or an equivalent combination of education, training & experience
  • At least 6 years of independent on-site monitoring experience or an equivalent experience in China
  • Experience in all types of monitoring visits in Phase II and/or III
  • Experience in feasibility assessment and study set-up process is preferable
  • Experience in Oncology or Hematology therapeutic indications is a plus (preferable)
  • Full working proficiency in English and Mandarin
  • PC skills to be able to work with MS Word, Excel and PowerPoint
  • Ability to plan, multitask and work in a dynamic team environment
  • Communication, collaboration, and problem-solving skills
  • Ability to travel

Additional Information

Advance your career in clinical research, coordinating a variety of tasks and learning new things while growing with a rapid growing company, that puts its people first!

Employer
PSI CRO AG
Location
Shanghai, China · On site
Contract
full-time