PPD Germany GmbH & Co KG
Clinical Trial Coordinator - FSP(m/w/x)
Full-timeWith HomeofficeNot specified
Karlsruhe
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THThermo Fisher Scientific
Assistant CRA - FSP(m/w/x)
Karlsruhe
Full-timeRemoteEntry Level
Nejo AI Summary
Remote site monitoring and data review for global clinical trials. Bachelor's degree in life science and clinical monitoring knowledge required. Flexible working models, award-winning learning and development.
Requirements
- Bachelor's degree in life science field
- 0-1 year clinical research experience
- Clinical monitoring knowledge via coursework/training
- Experience in clinical trials, data management, medical terminology, medical research, or health care
- Health sciences field experience with medical terminology and anatomy training
- Aspiration to advance into CRA role
- Basic medical/therapeutic area knowledge
- Basic understanding of medical terminology
- Working knowledge of ICH GCPs
- Working knowledge of applicable regulations
- Working knowledge of PPD procedural documents
- Ability to complete PPD's Clinical Foundation Training Program
- Ability to complete RSM Onboarding Workshop
- Fluency in German (minimum C1 Level)
- Fluency in English (minimum C1 Level)
- Ability to evaluate medical research data
- Ability to advise, counsel, and motivate investigational sites
- Effective oral and written communication skills
- Ability to communicate effectively with medical personnel
- Excellent interpersonal skills
- Excellent customer service skills
- Good organizational skills
- Good time management skills
- Proven flexibility
- Proven adaptability
- Strong attention to detail
- Ability to work in a team
- Ability to work independently
- Well-developed critical thinking skills
- Critical mindset
- In-depth investigation for root cause analysis
- Problem solving skills
- Ability to coach site personnel
- Ability to mentor site personnel
- Good computer skills
- Good MS Office knowledge
- Ability to learn and use appropriate software
- Leverage modern technology when applicable
- Ability to extract information from study documents
- Ability to extract information from electronic study systems
- Ability to extract information from CTMS
- Ability to extract information from dashboards
- Severely disabled applicants with same aptitude given preferential treatment
Tasks
- Perform remote site management and monitoring
- Review study data from various sources
- Contact study sites to collect documentation
- Resolve issues and request outstanding information
- Develop and maintain close communication with site staff
- Discuss protocol conduction and enrollment rates
- Address open issues and EDC completion queries
- Complete, track, and follow up ETRTR for subject data
- Raise manual queries in EDC when necessary
- Remotely review study logs as needed
- Conduct and document site management calls
- Participate in investigator meetings
- Investigate and follow up on centralized monitoring findings
- Evaluate PI oversight and subject safety
- Assess site’s ability to conduct the study
- Conduct remote investigations using risk-based monitoring
- Apply root cause analysis and problem-solving skills
- Identify and address site process failures
- Provide refresher training to site staff
- Follow up on outstanding administrative needs
- Assist with regulatory reviews
- Review ad-hoc clinical listings
- Track and trend violations and deviations
- Monitor site status, enrollment, and CRF status
- Follow up on SAEs
- Provide trial status tracking and progress reports
- Participate in the investigator payment process
- Liaise with internal staff for document collection
- Review data points and findings from EDC and file reviews
- Ensure audit-ready files and CTMS/eTMF data stewardship
- Contribute to regulatory requirements and audit responses
Education
- Vocational certificationOR
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- MS Office
Benefits
Career Advancement
- Long-term career opportunities
- Clear development pathways
Flexible Working
- Flexible working models
- Work-life balance
Learning & Development
- Award-winning learning and development programme
Competitive Pay
- Competitive salary
Other Benefits
- Extensive benefits package
- Health and well-being focus
Informal Culture
- Collaborative environment
Mentorship & Coaching
- Team expertise sharing
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Thermo Fisher Scientific and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
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THThermo Fisher Scientific
Assistant CRA - FSP(m/w/x)
Karlsruhe
Full-timeRemoteEntry Level
Nejo AI Summary
Remote site monitoring and data review for global clinical trials. Bachelor's degree in life science and clinical monitoring knowledge required. Flexible working models, award-winning learning and development.
Requirements
- Bachelor's degree in life science field
- 0-1 year clinical research experience
- Clinical monitoring knowledge via coursework/training
- Experience in clinical trials, data management, medical terminology, medical research, or health care
- Health sciences field experience with medical terminology and anatomy training
- Aspiration to advance into CRA role
- Basic medical/therapeutic area knowledge
- Basic understanding of medical terminology
- Working knowledge of ICH GCPs
- Working knowledge of applicable regulations
- Working knowledge of PPD procedural documents
- Ability to complete PPD's Clinical Foundation Training Program
- Ability to complete RSM Onboarding Workshop
- Fluency in German (minimum C1 Level)
- Fluency in English (minimum C1 Level)
- Ability to evaluate medical research data
- Ability to advise, counsel, and motivate investigational sites
- Effective oral and written communication skills
- Ability to communicate effectively with medical personnel
- Excellent interpersonal skills
- Excellent customer service skills
- Good organizational skills
- Good time management skills
- Proven flexibility
- Proven adaptability
- Strong attention to detail
- Ability to work in a team
- Ability to work independently
- Well-developed critical thinking skills
- Critical mindset
- In-depth investigation for root cause analysis
- Problem solving skills
- Ability to coach site personnel
- Ability to mentor site personnel
- Good computer skills
- Good MS Office knowledge
- Ability to learn and use appropriate software
- Leverage modern technology when applicable
- Ability to extract information from study documents
- Ability to extract information from electronic study systems
- Ability to extract information from CTMS
- Ability to extract information from dashboards
- Severely disabled applicants with same aptitude given preferential treatment
Tasks
- Perform remote site management and monitoring
- Review study data from various sources
- Contact study sites to collect documentation
- Resolve issues and request outstanding information
- Develop and maintain close communication with site staff
- Discuss protocol conduction and enrollment rates
- Address open issues and EDC completion queries
- Complete, track, and follow up ETRTR for subject data
- Raise manual queries in EDC when necessary
- Remotely review study logs as needed
- Conduct and document site management calls
- Participate in investigator meetings
- Investigate and follow up on centralized monitoring findings
- Evaluate PI oversight and subject safety
- Assess site’s ability to conduct the study
- Conduct remote investigations using risk-based monitoring
- Apply root cause analysis and problem-solving skills
- Identify and address site process failures
- Provide refresher training to site staff
- Follow up on outstanding administrative needs
- Assist with regulatory reviews
- Review ad-hoc clinical listings
- Track and trend violations and deviations
- Monitor site status, enrollment, and CRF status
- Follow up on SAEs
- Provide trial status tracking and progress reports
- Participate in the investigator payment process
- Liaise with internal staff for document collection
- Review data points and findings from EDC and file reviews
- Ensure audit-ready files and CTMS/eTMF data stewardship
- Contribute to regulatory requirements and audit responses
Education
- Vocational certificationOR
- Bachelor's degree
Languages
- German – Business Fluent
- English – Business Fluent
Tools & Technologies
- MS Office
Benefits
Career Advancement
- Long-term career opportunities
- Clear development pathways
Flexible Working
- Flexible working models
- Work-life balance
Learning & Development
- Award-winning learning and development programme
Competitive Pay
- Competitive salary
Other Benefits
- Extensive benefits package
- Health and well-being focus
Informal Culture
- Collaborative environment
Mentorship & Coaching
- Team expertise sharing
Find the original job posting in its most current version here. Nejo automatically captured this job from the website of Thermo Fisher Scientific and processed the information on Nejo with the help of AI for you. Despite careful analysis, some information may be incomplete or inaccurate. Please always verify all details in the original posting! Content and copyrights of the original posting belong to the advertising company.
About the Company
Thermo Fisher Scientific
Industry
Pharmaceuticals
Description
The company enables customers to make the world healthier, cleaner, and safer through innovative scientific solutions.
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