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BeOne Medicines

Clinical Research Associate II

BeOne Medicines

. Assume the role of a primary CRA and function as the site manager .

Posted 11/9/2026full-timeRemote • United StatesJuniorMid-Level💰 $92,000 - $122,000 per yearWebsite

Core Competencies

Role fit
Core Competencies

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Demonstrates expertise in clinical monitoring and site management, ensuring compliance with ICH-GCP guidelines and local regulations while effectively communicating with clinical study teams and mentoring junior CRAs.

Highest-signal resume keywords
Clinical Monitoring ExperienceICH-GCP ComplianceOncology Trials ExperienceData Management Systems FamiliaritySite Management Skills

ATS Keywords

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Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills
Clinical OperationsMonitoring ExperienceProtocol ComplianceData Quality MonitoringPatient Safety Assessment
Soft Skills
Relationship BuildingCommunication SkillsMentoring Ability
Tools & Technologies
Microsoft WordMicrosoft ExcelMicrosoft PowerPointMicrosoft OutlookCTMS
Industry Keywords
Clinical Research AssociateSite VisitsSerious Adverse Events ReconciliationEnrollment TrackingRegulatory Guidelines

About the role

Key responsibilities & impact
  • Assume the role of a primary CRA and function as the site manager
  • Conduct site visits, including PSSV, SIV, IMV, and COV
  • Build and maintain relationships with key site personnel
  • Monitor data quality and patient safety through monitoring and site education
  • Complete all aspects of clinical monitoring in accordance with ICH-GCP guidelines, local regulations, and applicable SOPs
  • Assess the safety and efficacy of investigational products and/or medical devices
  • Conduct site visits to determine protocol and regulatory compliance and prepare required documentation
  • Develop collaborative relationships with investigative sites and study vendors
  • Provide protocol and study training to assigned clinical study sites
  • Maintain oversight of site performance by tracking enrollment, CRF data entry, protocol deviation trends, and site issues
  • Mentor and train less experienced CRAs
  • Communicate site performance to the Clinical Study Team
  • Perform study-specific training with the project team
  • Reconcile Serious Adverse Events and resolve discrepancies with study sites
  • Collaborate with the CST and clinical study sites to deliver study milestones
  • Attend regional investigator meetings and site booster visits as required
  • Support audit and inspection preparation and follow quality findings to resolution
  • Provide site-level management and co-monitoring support

Requirements

What you’ll need
  • BS/BA in a relevant scientific discipline
  • Minimum of 2+ years of relevant Clinical Operations experience
  • Minimum of 1+ years of monitoring experience
  • Experience in global oncology trials preferred
  • Efficient in Microsoft Word, Excel, PowerPoint and Outlook
  • Familiar with industry CTMS and data management systems
  • Thorough knowledge of ICH and associated regulatory guidelines
  • Fluent in English (writing and speaking)
  • Up to 70% travel

Benefits

Comp & perks
  • Annual bonus plan eligibility for non-commercial roles
  • Incentive compensation plan eligibility for commercial roles
  • Discretionary equity awards
  • Employee Stock Purchase Plan
  • Medical insurance
  • Dental insurance
  • Vision insurance
  • 401(k)
  • FSA/HSA
  • Life Insurance
  • Paid Time Off
  • Wellness