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Posted: 10/20/2026Clinical Research Associate II
BeOne MedicinesCore Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Clinical Research Operations, including monitoring, site management, and adherence to ICH-GCP guidelines. Proficient in building relationships with clinical sites and ensuring compliance with regulatory standards while effectively communicating with study teams.
Highest-signal resume keywords
Clinical Research Associate ExperienceMonitoring ExperienceKnowledge of ICH-GCP GuidelinesExperience in Global Oncology TrialsBS/BA in Relevant Scientific Discipline
About the role
Key responsibilities & impact- Serve as the primary Clinical Research Associate and site manager
- Conduct pre-study, site initiation, interim monitoring, and closeout visits
- Build and maintain relationships with key site personnel
- Monitor data quality and patient safety through monitoring and site education
- Complete clinical monitoring activities in accordance with ICH-GCP guidelines, local regulations, and SOPs
- Assess the safety and efficacy of investigational products and/or medical devices
- Conduct site visits to determine protocol and regulatory compliance and prepare documentation
- Develop collaborative relationships with investigative sites and study vendors
- Provide protocol and study training to clinical study sites
- Track enrollment, CRF data entry, protocol deviations, 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 Clinical Study Team and sites to deliver study milestones
- Attend investigator meetings and site booster visits
- Support audit and inspection preparation and resolve quality findings
- Provide site-level management and co-monitoring support as needed
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
- Employee Stock Purchase Plan
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k)
- FSA/HSA
- Life insurance
- Paid Time Off
- Wellness benefits
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Monitoring ActivitiesData Quality MonitoringProtocol Compliance AssessmentCRF Data Entry TrackingSerious Adverse Events Reconciliation
Soft Skills
Excellent Communication SkillsInterpersonal SkillsOrganizational SkillsAbility to PrioritizeMentoring Skills
Tools & Technologies
Microsoft WordMicrosoft ExcelMicrosoft PowerPointMicrosoft OutlookCTMS
Industry Keywords
Clinical OperationsSite ManagementInvestigational ProductsRegulatory ComplianceClinical Study Training