IQVIA
Clinical Research Associate or SrCRA(m/w/x)
Vollzeit
mit Homeoffice
Berufserfahren
Keine Angabe
Basel
TH
Thermo Fisher Scientific3 Monate
Sr CRA (Level I)(m/w/x)
Vollzeit
Remote
Berufserfahren
Keine Angabe
Basel
Nejo KI-Zusammenfassung
In this role, you will coordinate clinical monitoring and site management, ensuring compliance with protocols and regulations. Your day-to-day responsibilities will involve assessing site performance, maintaining data accuracy, and fostering communication among stakeholders to support successful clinical trials.
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Anforderungen
- •Two or more years of onsite monitoring experience
- •Experience monitoring oncology
- •Bachelor's degree in life sciences or Registered Nursing certification or equivalent
- •Previous experience comparable to 2+ years as a clinical research monitor
- •Effective clinical monitoring skills
- •Understanding of medical/therapeutic area knowledge and medical terminology
- •Understanding and application of ICH GCPs and applicable regulations
- •Well-developed critical thinking skills
- •Management of Risk Based Monitoring concepts and processes
- •Effective oral and written communication skills
- •Customer focus and good listening skills
- •Ability to travel frequently to study sites
- •Effective interpersonal 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
- •German and English skills mandatory; Italian or French required
- •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 protocol compliance
- •Manage documentation for various sponsors and monitoring environments
- •Ensure trials adhere to approved protocols and ICH-GCP guidelines
- •Maintain audit readiness and develop relationships with investigational sites
- •Monitor investigator sites using a risk-based approach
- •Apply root cause analysis to identify site process failures
- •Ensure data accuracy through review of SDR, SDV, and CRF
- •Assess investigational product through inventory and records review
- •Document observations in reports and letters promptly
- •Escalate deficiencies and issues to clinical management quickly
- •Maintain contact with investigative sites between monitoring visits
- •Conduct monitoring tasks per the approved monitoring plan
- •Participate in the investigator payment process
- •Provide trial status updates to the Clinical Team Manager
- •Ensure study systems are updated according to 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
- •Complete essential documents per ICH-GCP regulations
- •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
Tools & Technologien
Microsoft Office
Sprachen
Deutsch – verhandlungssicher
Englisch – fließend
Italienisch – Grundkenntnisse
Französisch – Grundkenntnisse
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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