Precision Medicine Group is looking for a Clinical Research Associate II to provide critical support to study sites and clinical project teams. You will act as the main point of contact for sites, overseeing all aspects of study site management to ensure patient safety and data integrity. At Precision, we are not your typical CRO; we focus on integrating deep scientific knowledge with clinical trial execution, particularly in Oncology and Rare Disease.
What You'll Do
- Oversee all aspects of study site management to ensure patient safety and data quality.
- Provide guidance towards audit readiness standards and support audit preparation.
- Update, track, and maintain study-specific trial management tools, systems, and status reports.
- Manage site start-up procedures including feasibility assessments, EC/IRB submissions, and regulatory document collection.
- Assist with the negotiation of study budgets and the execution of investigator contracts.
- Verify the informed consent process for each study subject.
- Assess factors affecting subject safety and data integrity at investigator sites.
- Independently conduct all forms of site visits, including pre-study, initiation, monitoring, and close-out.
- Prepare and submit accurate and timely monitoring reports from all site visits.
- Document activities via confirmation letters, follow-up letters, trip reports, and communication logs.
- Support subject recruitment, retention, and awareness strategies.
- Routinely review the Investigator Site File for accuracy and reconcile it with the Trial Master File.
- Communicate effectively with site personnel and project management to relay protocol and study issues.
- Develop and maintain good working relationships with investigators and study staff.
- Perform investigational product inventory, reconciliation, and review storage and security.
- Perform data review activities, including remote EDC CRF review and query resolution.
- Identify and process Serious Adverse Events according to study procedures.
- Identify site risks and escalate them to management with suggested contingencies.
- Prepare for and attend Investigator Meetings and sponsor face-to-face meetings.
- Participate in global clinical monitoring/project staff meetings and clinical training sessions.
- Travel as necessary according to project needs.
What We're Looking For
- Bachelor's degree, international equivalent, or equivalent combination of education and experience, ideally in a business, scientific, or healthcare discipline.
- Minimum of 2 years of on-site monitoring experience.
- Minimum of 1 year of oncology experience.
- Global Clinical Trial experience.
- High proficiency in Microsoft Office (Outlook, Word, Excel, PowerPoint).
- Customer service demeanor; demonstrates flexibility and teamwork.
- Ability to focus on detail for extended periods with high attention to accuracy.
- Fluency in English communication, both verbally and in writing.
- Working knowledge of the drug development process.
- Ability to travel 60-70%.
Nice to Have
- Solid experience in clinical research or a related field.
- Excellent organizational skills.
- Ability to work efficiently in a remote work environment.
Technical Stack
- Microsoft Office Suite: Outlook, Word, Excel, PowerPoint
Team & Environment
You will work as a study team member with support from a Clinical Trial Manager or Project Manager, reporting directly to that role.
Work Mode
This role is local-country and open to candidates in a remote capacity within China, specifically in Shanghai or Beijing.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.


