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Clinical Research Associate(m/w/x)
Overseeing oncology and hematology trials at a patient advocacy organization. Minimum 2 years monitoring experience required, oncology global trials experience preferred. Regular travel to trial sites.
Requirements
- BS in relevant scientific discipline
- Minimum 2 years monitoring experience
- Experience in oncology global trials preferred
- Understanding of clinical trial processes
- Knowledge of ICH and regulatory guidelines
- 2 years pharmaceutical/CRO monitoring experience
- Experience in oncology/hematology trials preferred
- Excellent communication and interpersonal skills
- Excellent organizational and multi-tasking skills
- Fluency in English and German
- Efficiency in Microsoft Office and Outlook
Tasks
- Execute clinical monitoring at trial sites
- Adhere to ICH guidelines and GCP standards
- Perform site selection and initiation activities
- Monitor oncology and hematology clinical trials
- Collaborate with the Regional Clinical Operations Manager
- Maintain study timelines and quality standards
- Identify gaps and propose corrective actions
- Support study start-up with local expertise
- Conduct site identification and feasibility assessments
- Provide protocol training to assigned sites
- Perform routine monitoring and closeout visits
- Complete detailed monitoring visit reports
- Track regulatory submissions and recruitment progress
- Manage CRF completion and data query resolution
- Maintain regular communication with clinical sites
- Ensure inspection readiness for all studies
- Facilitate site audits and oversight visits
- Escalate quality and GCP issues appropriately
- Attend disease-specific and general CRA training
Work Experience
- 2 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- Microsoft Word
- Excel
- MS Project
- MS PowerPoint
- Outlook
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Clinical Research Associate(m/w/x)
Overseeing oncology and hematology trials at a patient advocacy organization. Minimum 2 years monitoring experience required, oncology global trials experience preferred. Regular travel to trial sites.
Requirements
- BS in relevant scientific discipline
- Minimum 2 years monitoring experience
- Experience in oncology global trials preferred
- Understanding of clinical trial processes
- Knowledge of ICH and regulatory guidelines
- 2 years pharmaceutical/CRO monitoring experience
- Experience in oncology/hematology trials preferred
- Excellent communication and interpersonal skills
- Excellent organizational and multi-tasking skills
- Fluency in English and German
- Efficiency in Microsoft Office and Outlook
Tasks
- Execute clinical monitoring at trial sites
- Adhere to ICH guidelines and GCP standards
- Perform site selection and initiation activities
- Monitor oncology and hematology clinical trials
- Collaborate with the Regional Clinical Operations Manager
- Maintain study timelines and quality standards
- Identify gaps and propose corrective actions
- Support study start-up with local expertise
- Conduct site identification and feasibility assessments
- Provide protocol training to assigned sites
- Perform routine monitoring and closeout visits
- Complete detailed monitoring visit reports
- Track regulatory submissions and recruitment progress
- Manage CRF completion and data query resolution
- Maintain regular communication with clinical sites
- Ensure inspection readiness for all studies
- Facilitate site audits and oversight visits
- Escalate quality and GCP issues appropriately
- Attend disease-specific and general CRA training
Work Experience
- 2 years
Education
- Bachelor's degree
Languages
- English – Business Fluent
- German – Business Fluent
Tools & Technologies
- Microsoft Word
- Excel
- MS Project
- MS PowerPoint
- Outlook
Like this job?
BetaYour Career Agent finds similar jobs for you every day.
About the Company
BeOne Medicines Germany GmbH
Industry
Pharmaceuticals
Description
The company is focused on advancing public policy objectives and advocating for patient access to therapies in the healthcare sector.
Not a perfect match?
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