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Clinical Research Associate
BeOne MedicinesClinical Research Associate executing clinical monitoring activities at clinical trial sites for BeOne. Ensuring adherence to study timelines and quality standards in oncology trials.
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Execute clinical monitoring activities at clinical trial sites
- Monitor clinical trials in accordance with ICH guidelines and GCP, local regulations, and applicable SOPs
- Collaborate closely with the Country and Regional Clinical Study Teams to ensure study timelines are adhered to and required quality standards are maintained
- Identify gaps and areas for improvement and propose CAPA
- Support start-up activities
- Conduct site selection and evaluation
- Provide protocol and related study training to assigned sites
- Conduct onsite/remote pre-study, initiation, routine monitoring and closeout visits per monitoring plan
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans
- Manage sites and site performance by tracking regulatory submissions, recruitment, case report form completion, and data query resolution
- Ensure inspection readiness of study and sites
Requirements
What you’ll need- 1+ years of experience in oncology/onco-hematology trials
- Good knowledge of applicable clinical research regulatory requirements, i.e., Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and associated regulatory guidelines.
- Monitoring experience in the pharmaceutical or CRO industry preferred
- Experience in oncology/onco-hematology trials preferred
- Excellent communication and interpersonal skills
- Ability to establish and maintain effective working relationships with coworkers, managers, and other internal/external stakeholders as applicable
- Good organizational and problem-solving skills and ability to prioritize and multi-task
- Effective time management skills
- Written and verbal communication skills including good command of English language and German.
Benefits
Comp & perks- Health insurance
- Flexible work hours
- Professional development
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical monitoringsite selectionprotocol trainingmonitoring plan executionregulatory submissions trackingdata query resolutionCAPAdocumentation managementoncology trialsonco-hematology trials
Soft Skills
communication skillsinterpersonal skillsorganizational skillsproblem-solving skillstime management skillsrelationship buildingmulti-taskingprioritization