Clinical Research Associate II, FSP

September 25

Apply Now

Receive Emails with Similar Jobs

Parexel

WebsiteLinkedInAll Job Openings

Healthcare Insurance • Biotechnology • Pharmaceuticals

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

📋 Description

• Conduct source data verification (SDV) and ensure clinical trials data are submitted to data management in a timely fashion • Identify issues impacting study conduct and ensure appropriate closure of all issues • Proactively manage investigator site workload to ensure efficient study conduct and meet key objectives • Ensure studies are run in line with ICH/GCP, local laws and Client SOPs • Ensure patient safety and report safety issues according to regulatory requirements • Inform Principal Investigator (PI) and site staff of issues and agree corrective/preventative actions • Responsible for site management from site selection collaboration through study closeout and train site staff on protocol and processes • Ensure data quality standards are met and data entered into Client systems timely • Report progress after each visit, catalog and manage issues to closure, and maintain site-level clinical trials registry • Obtain information for Investigator Initiation Package (IIP); assist CTA with IIP documentation and maintain Site Master File (SMF) and SMF log • Ensure Electronic Library and Records Archive (ELARA) and/or Client Trial Master File (TMF) completeness; QC relevant documents and generate site monitoring reports • Comply with required training, timesheet submission, expense reports, CV updates, and maintain knowledge of Parexel processes and ICH-GCPs

🎯 Requirements

• At least 1.5 years (2 years preferable) of Clinical Monitoring/ Site Management experience • Global study monitoring experience preferred • Good knowledge of ICH/GCP and relevant international and local regulations relating to Clinical Research • Degree in Life Science, Nursing, Pharmacy, or other relevant education background • Bachelor’s degree or above, or equivalent • Proficient in Chinese; good command of written and spoken English • Computer literacy (word processing, spreadsheets, PowerPoint) • Good interpersonal and communication skills • Ability to manage multiple tasks, prioritize workload, and pay attention to detail • Willingness to work in a matrix environment and to value teamwork