Thermo Fisher Scientific
Clinical Trial Coordinator II(m/w/x)
Vollzeit
mit Homeoffice
Keine Angabe
Karlsruhe
TH
Thermo Fisher Scientific1 Monat
Senior CRA I/II(m/w/x)
Vollzeit
Remote
Senior
Keine Angabe
Karlsruhe, München
Nejo KI-Zusammenfassung
In this role, you will coordinate clinical monitoring and site management, ensuring compliance with protocols and regulations. Your daily responsibilities will include building relationships with investigational sites, conducting visits, and maintaining data accuracy to support successful clinical trials.
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Anforderungen
- •Bachelor's degree in life sciences or equivalent qualification
- •Previous experience comparable to 2+ years as a clinical research monitor
- •Valid driver's license
- •Full right to work in Germany
- •Fluency in English and German to at least C1 level
- •Effective clinical monitoring skills
- •Understanding of medical/therapeutic area knowledge and terminology
- •Understanding and application of ICH GCPs and regulations
- •Well-developed critical thinking skills
- •Ability to handle Risk Based Monitoring concepts
- •Effective oral and written communication skills
- •Customer focus with good listening skills
- •Effective social skills
- •Strong attention to detail
- •Effective organizational and time management skills
- •Flexibility and adaptability in various scenarios
- •Ability to work in a team or independently
- •Good computer skills: proficient in Microsoft Office
- •Good presentation skills
Bachelor-Abschluss
ODER
Abgeschlossene Berufsausbildung
Berufserfahrung
2 Jahre
Deine Aufgaben
- •Perform and coordinate clinical monitoring and site management
- •Conduct remote or on-site visits to assess compliance
- •Manage required documentation for clinical trials
- •Ensure trials adhere to approved protocols and regulations
- •Maintain audit readiness at all times
- •Develop collaborative relationships with investigational sites
- •Monitor investigator sites using a risk-based approach
- •Apply root cause analysis to identify and resolve site issues
- •Ensure data accuracy through review of SDR, SDV, and CRF
- •Assess investigational products through inventory and records review
- •Document observations in reports and letters promptly
- •Communicate deficiencies and issues to clinical management quickly
- •Maintain regular contact with investigative sites between visits
- •Conduct monitoring tasks per the approved monitoring plan
- •Participate in the investigator payment process
- •Collaborate with project team on issue resolution
- •Investigate and follow up on findings as necessary
- •Provide trial status updates to the Clinical Team Manager
- •Update study systems according to study conventions
- •Perform quality checks on reports from the CTMS
- •Participate in investigator meetings as needed
- •Identify potential investigators in collaboration with clients
- •Initiate clinical trial sites to ensure compliance
- •Ensure trial closeout and retrieval of trial materials
- •Verify essential documents are complete and compliant
- •Conduct on-site file reviews as specified
- •Assist in preparing project publications and tools
- •Facilitate communication between sites, clients, and project teams
- •Respond to regulatory requirements and audits
- •Complete administrative tasks like expense reports and timesheets
- •Contribute to process improvement initiatives as required
Sprachen
Deutsch – verhandlungssicher
Englisch – verhandlungssicher
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.
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