Clinical Research Associate II

BeOne Medicines

. Perform and coordinate assigned aspects of the clinical monitoring process in accordance with GCPs and SOPs .

Posted 11/11/2026full-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 processes, regulatory compliance, and protocol adherence while effectively managing relationships with clinical study sites. Proficient in data management and communication, ensuring successful study execution and milestone delivery.

Highest-signal resume keywords

Clinical Operations ExperienceMonitoring ExperienceKnowledge of ICH GuidelinesProficient in Microsoft Office SuiteExperience in Global Oncology Trials

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical MonitoringProtocol ComplianceData ManagementSAE ReconciliationCRF Data EntrySite Performance CommunicationStudy TrainingEnrollment TrackingRegulatory DocumentationQuality Issue Resolution

Soft Skills

Excellent Communication SkillsInterpersonal SkillsOrganizational SkillsAbility to PrioritizeMulti-tasking Ability

Tools & Technologies

CTMSData Management SystemsMicrosoft WordMicrosoft ExcelMicrosoft PowerPointMicrosoft Outlook

Industry Keywords

GCPSOPClinical Study TeamOncology TrialsSite VisitsInvestigator MeetingsAudit PreparationClinical Study SitesStudy MilestonesProtocol Deviation Trends

About the role

Key responsibilities & impact

Perform and coordinate assigned aspects of the clinical monitoring process in accordance with GCPs and SOPs
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 related study training to assigned clinical study sites
Attend disease indication, project-specific, regional investigator meeting and site booster training as required
Track enrollment, CRF data entry, protocol deviation trends and overall site issues
Serve as mentor/trainer for less experienced CRAs
Communicate site performance to the Clinical Study Team
Perform study-specific training with the project team
Perform SAE reconciliation and resolve discrepancies with study sites
Collaborate with the CST and clinical study sites to deliver study milestones, including startup, recruitment, database analyses and closeout
Support audit/inspection preparation and follow quality issues or findings through resolution
Provide site-level management for established protocols and portfolios
Co-monitor with CRAs and support site visits as needed
Assist with other assigned clinical responsibilities

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
Excellent communication and interpersonal skills
Excellent organizational skills and ability to prioritize and multi-task
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
Voluntary participation in the Employee Stock Purchase Plan
Medical insurance
Dental insurance
Vision insurance
401(k)
FSA/HSA
Life insurance
Paid Time Off
Wellness