Senior Clinical Research Associate

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 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. 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!