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.
- 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
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!