Senior Clinical Research Associate

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. 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!