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Clinical Research Associate I – Oncology
BeOne Medicines. Conduct pre-study, initiation, routine monitoring, closeout, and co-monitoring visits for Oncology and Hematology clinical trials .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing Oncology and Hematology clinical trials, ensuring compliance with ICH-GCP standards and effective communication with clinical sites. Proficient in coordinating study milestones, regulatory submissions, and quality oversight while maintaining strong organizational skills.
Highest-signal resume keywords
Clinical Research Coordinator ExperienceOncology KnowledgeICH-GCP ComplianceRegulatory Submissions ManagementExcellent Communication Skills
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 Trial ProcessesData Management SystemsQuality Oversight VisitsMonitoring Visit ReportsProtocol TrainingSite Practice EvaluationRecruitment StrategiesDatabase AnalysisCRF CompletionBudget Negotiations
Soft Skills
Excellent CommunicationInterpersonal SkillsOrganizational SkillsMulti-tasking AbilityPrioritization Skills
Tools & Technologies
Microsoft WordMicrosoft ExcelMicrosoft PowerPointMicrosoft OneNoteMicrosoft OutlookEMR SystemsCTMSSite File Management
Industry Keywords
OncologyHematologyClinical TrialsICH GuidelinesGCPEthics CommitteeEarly Phase ExperienceSolid Tumor Experience
About the role
Key responsibilities & impact- Conduct pre-study, initiation, routine monitoring, closeout, and co-monitoring visits for Oncology and Hematology clinical trials
- Ensure study milestones, including startup, recruitment, database analyses, and closeout, are met
- Attend onboarding, disease indication, project-specific, and CRA training
- Document monitoring activities according to ICH-GCP and BeOne standards
- Conduct Quality Oversight Visits as requested
- Complete monitoring visit and QOV reports on time
- Assist with investigator/site identification and Ethics Committee submissions
- Facilitate clinical trial site contract and budget negotiations
- Manage site queries and communications
- Assist in managing clinical trials as required
- Establish regular communication with sites and Clinical Operations Managers
- Provide protocol and study training to assigned sites
- Evaluate site practice quality and integrity, escalating quality issues as appropriate
- Track regulatory submissions, recruitment, CRF completion, and data query resolution
- Collaborate with the CRA Group and CRM on recruitment and contingency plans
- Deliver quality data within timelines and ensure adherence to monitoring procedures, GCP, ICH, local regulations, and SOPs
Requirements
What you’ll need- At least 2 years of Clinical Research Coordinator experience in Oncology
- Thorough knowledge of clinical trial processes, 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)
- Efficient in Microsoft Word, Excel, PowerPoint, OneNote, and Outlook
- Familiarity with industry EMR, CTMS, Site File Management, and data management systems
- Bachelor’s degree or above in life sciences, pharmacy, nursing, or medical
- Up to 70% multi-regional travel
- Early Phase experience preferred
- Hematology and Solid Tumor experience preferred
Benefits
Comp & perks- Annual bonus plan eligibility for non-commercial roles
- Incentive compensation plan eligibility for commercial roles
- Discretionary equity awards
- Voluntary Employee Stock Purchase Plan participation
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k)
- FSA/HSA
- Life insurance
- Paid Time Off
- Wellness benefits