Senior Clinical Research Associate

Company Description

PSI is a leading Contract Research Organization (CRO) with 30 years of experience in the pharmaceutical industry. Originated in Switzerland, PSI is a privately owned, full-service CRO with a global reach, supporting clinical trials across multiple countries and continents. Our reputation for being highly selective about the projects we undertake highlights our commitment to delivering high-quality, timely services across a broad spectrum of therapeutic indications.

At PSI, we foster an environment where a diverse range of colleagues feel welcomed and valued. Our inclusive culture is a cornerstone of our success, enabling us to attract and retain top talent globally.

We are not just about conducting clinical trials; we are about building a community where every team member has the opportunity to thrive and contribute to groundbreaking advancements in the pharmaceutical industry.

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!