Clinical Research Associate (Oncology)

TL;DR

CRA II (Oncology): Provides overall support to study sites and clinical project teams in clinical research studies with an accent on site management, patient safety, data quality, and regulatory compliance. Focus on conducting site visits, monitoring protocol adherence, managing investigational products, and ensuring audit readiness.

Remote, China. Based in Shanghai/Beijing. Travelling required (60-70%).

Company

CRO integrating clinical trial execution with scientific knowledge, laboratory expertise, and advanced data sciences, with strong focus on Oncology and Rare Disease.

What you will do

• Oversee study site management to protect patient safety and ensure high data quality with low query levels.
• Conduct all forms of site visits (pre-study, initiation, routine monitoring, close-out) and prepare accurate monitoring reports.
• Manage site start-up, regulatory documents, informed consent, budgets, and investigator contracts as required.
• Review and reconcile Investigator Site File (ISF) with Trial Master File (TMF), handle IP inventory and reconciliation.
• Perform data review, SAE processing, risk identification, and escalation to project manager.
• Communicate proactively with sites and project teams, support recruitment strategies, and attend investigator meetings.

Requirements

• Bachelor's degree or equivalent in business, scientific, or healthcare discipline.
• Minimum 2 years of on-site monitoring experience; 1 year oncology trial experience preferred.
• Fluency in English communication, verbally and in writing.
• Working knowledge of drug development process and ICH-GCP.
• High proficiency in Microsoft Office (Outlook, Word, Excel, PowerPoint).
• Customer service demeanor, flexibility, teamwork, attention to detail.

Nice to have

• Solid experience in clinical research.
• Excellent organizational skills.
• Ability to work efficiently in remote environment.

Culture & Benefits

• Strong focus on employee appreciation and idea nurturing for positive change.
• Commitment to professional performance aligned with company principles.
• Equal opportunity employer.