Thermo Fisher Scientific
CRA - FSP(m/w/x)
Vollzeit
Remote
Berufseinsteiger
Keine Angabe
Reinach
PP
PPD Switzerland GmbH5 Tage
CRA II / Sr CRA - FSP(m/w/x)
Vollzeit
Remote
Junior
Keine Angabe
Reinach
Nejo KI-Zusammenfassung
As a Clinical Research Associate, you will engage in a variety of tasks, including conducting compliance visits and managing site relationships to ensure trials run smoothly and data remains accurate. This role involves problem-solving and collaboration to uphold the highest standards in clinical research.
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Anforderungen
- •Bachelor's degree in life sciences or Registered Nursing certification or equivalent
- •Previous experience comparable to 1 year as a clinical research monitor or completion of PPD Drug Development Fellowship
- •Valid driver's license where applicable
- •Proven clinical monitoring skills
- •Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
- •Demonstrated ability to maintain knowledge of ICH GCPs and applicable regulations
- •Well-developed critical thinking skills
- •Ability to manage Risk Based Monitoring concepts and processes
- •Good oral and written communication skills
- •Ability to maintain customer focus with good listening skills
- •Good organizational and time management skills
- •Effective interpersonal skills
- •Attention to detail
- •Ability to remain flexible and adaptable
- •Ability to work in a team or independently
- •Good computer skills: knowledge of Microsoft Office and ability to learn software
- •Good English language and grammar skills
- •Good presentation skills
Bachelor-Abschluss
ODER
Abgeschlossene Berufsausbildung
Berufserfahrung
1 Jahr
Deine Aufgaben
- •Perform and coordinate clinical monitoring and site management
- •Conduct remote or on-site visits to assess compliance with protocols and regulations
- •Manage procedures and guidelines from various sponsors and monitoring environments
- •Ensure trials adhere to approved protocols, ICH-GCP guidelines, and applicable regulations
- •Maintain audit readiness and build relationships with investigational sites
- •Monitor investigator sites using a risk-based approach
- •Apply root cause analysis to identify and resolve site process failures
- •Ensure data accuracy through review of SDR, SDV, and CRF
- •Assess investigational products through inventory and records review
- •Document observations in reports and letters using approved standards
- •Escalate deficiencies and issues to clinical management promptly
- •Maintain regular contact with investigative sites between monitoring visits
- •Conduct monitoring tasks per the approved monitoring plan
- •Participate in the investigator payment process
- •Collaborate with project team members on issue resolution
- •Investigate and follow up on findings as necessary
- •Participate in investigator meetings as needed
- •Identify potential investigators in collaboration with the client company
- •Initiate clinical trial sites to ensure compliance with protocols and regulations
- •Perform trial closeout and retrieve trial materials
- •Ensure essential documents are complete and compliant with ICH-GCP
- •Conduct on-site file reviews as per project specifications
- •Provide trial status updates to the Clinical Team Manager
- •Update study systems according to agreed conventions
- •Facilitate communication between investigative sites, the client company, and the project team
- •Respond to company, client, and regulatory requirements and audits
- •Complete administrative tasks such as expense reports and timesheets
- •Assist in preparing project publications and sharing ideas with team members
- •Contribute to process improvement initiatives as required
Sprachen
Englisch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens PPD Switzerland GmbH 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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