Company Description
PSI is a leading Contract Researchganization (CRO) with 30 years of experience in the pharmaceutical industry.iginated in Switzerland, PSI is a privately owned, full-service CRO with a global reach, supporting clinical trials across multiple countries continents. Our reputation fbeing highly selective about the projects we undertake highlights our commitment to delivering high-quality, timely services across a broad spectrum of therapeutic indications.
Job Description
As a SeniCRA at PSI you will enjoy a variety of monitoring tasks 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, sponstrial sites;
- Maintain good relationships with site staff.
Site Monitoring:
- Perform full‑cycle site visits (selection, initiation, routine, close‑out);
- Drive enrollment timeline delivery;
- Handle AE/deviation communications, SDV, data queries trial risk management;
- Manage investigational products trial supplies;
- Ensure site‑level quality, data integrity ISF/TMF compliance;
- Support audit preparation, finding resolution CAPA activities.
Site Management:
- Coordinate document supply logistics among sites, labs warehouse;
- Support site contracting & payment; provide investigattraining newsletter inputs.
Trial Records:
- Maintain trial tracking systems;
- Assist regulatory/ethics submissions, IP‑RED collection TMF reconciliation;
- Review translated trial records upon manager approval.
Lead Monitoring:
- Oversee site feasibility start‑up; review regulatory/IP‑RED documents;
- Track enrollment/timelines implement corrective‑preventive actions;
- Review monitoring reports, drive query resolution manage regional clinical supplies;
- Act as key contact fmonitors project leadership;
- Lead country‑level project calls, supervise audit activities, report project status, deliver investigator‑meeting presentations mentjunimonitors.
Other departmental assignments, as necessary.
Qualifications
- Bachelors above degree in Life Sciences, Pharmacy, RN an equivalent combination of education, training & experience;
- At least 6 years of independent on-site monitoring experience an equivalent experience in China;
- Experience in all types of monitoring visits in Phase II and/III;
- Experience in feasibility assessment study set-up process is preferable;
- Experience in Oncology Hematology therapeutic indications is a plus (preferable);
- Full working proficiency in English Mandarin;
- PC skills to be able to work with MS Word, Excel PowerPoint；
- Ability to plan, multitask work in a dynamic team environment；
- Communication, collaboration, problem-solving skills;
- Ability to travel.
Additional Information
Advance your career in clinical research, coordinating a variety of tasks learning new things while growing with a rapid growing company, that puts its people first!
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