PPD Germany GmbH & Co KG
Clinical Trial Coordinator - FSP(m/w/x)
Vollzeitmit HomeofficeKeine Angabe
Karlsruhe
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
THThermo Fisher Scientific
Assistant CRA - FSP(m/w/x)
Karlsruhe
VollzeitRemoteBerufseinsteiger
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Ausbildung
- Abgeschlossene BerufsausbildungODER
- Bachelor-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Tools & Technologien
- MS Office
Benefits
Karriere- und Weiterentwicklung
- Long-term career opportunities
- Clear development pathways
Flexibles Arbeiten
- Flexible working models
- Work-life balance
Weiterbildungsangebote
- Award-winning learning and development programme
Attraktive Vergütung
- Competitive salary
Sonstige Vorteile
- Extensive benefits package
- Health and well-being focus
Lockere Unternehmenskultur
- Collaborative environment
Mentoring & Coaching
- Team expertise sharing
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Thermo Fisher Scientific erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Noch nicht perfekt?
- Thermo Fisher Scientific
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THThermo Fisher Scientific
Assistant CRA - FSP(m/w/x)
Karlsruhe
VollzeitRemoteBerufseinsteiger
Nejo KI-Zusammenfassung
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.
Anforderungen
- 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
Aufgaben
- 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
Ausbildung
- Abgeschlossene BerufsausbildungODER
- Bachelor-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Tools & Technologien
- MS Office
Benefits
Karriere- und Weiterentwicklung
- Long-term career opportunities
- Clear development pathways
Flexibles Arbeiten
- Flexible working models
- Work-life balance
Weiterbildungsangebote
- Award-winning learning and development programme
Attraktive Vergütung
- Competitive salary
Sonstige Vorteile
- Extensive benefits package
- Health and well-being focus
Lockere Unternehmenskultur
- Collaborative environment
Mentoring & Coaching
- Team expertise sharing
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Thermo Fisher Scientific erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Über das Unternehmen
Thermo Fisher Scientific
Branche
Pharmaceuticals
Beschreibung
The company enables customers to make the world healthier, cleaner, and safer through innovative scientific solutions.
Noch nicht perfekt?
- PPD Germany GmbH & Co KG
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Inside Sales Associate – Laboratory Service Sales (German-speaker)(m/w/x)
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