Thermo Fisher Scientific
Senior CRA I/II(m/w/x)
Vollzeit
Remote
Senior
Keine Angabe
Karlsruhe, München
AL
Alira Health GmbH5 Monate
Senior Clinical Research Associate(m/w/x)
Vollzeit
Remote
Senior
Keine Angabe
München
Nejo KI-Zusammenfassung
As a Senior Clinical Research Associate, you will play a vital role in overseeing clinical trials, ensuring compliance, and providing guidance to the CRA team. Daily tasks will involve site monitoring, problem-solving, and collaborating with various departments to support study success.
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Anforderungen
- •BS/BA from an undergraduate program in life sciences or related discipline
- •3 years of experience in pharmaceutical/biotechnology/CRO industry
- •2 years of clinical monitoring experience
- •1 year of management experience
- •Minimum 2 years of clinical monitoring experience
- •Ability to autonomously manage monitoring activities
- •Quality focused and detail-oriented
- •Strong organizational skills
- •Ability to multi-task and work effectively in a fast-paced environment
- •Ability to manage priorities and solve problems
- •Strong analytical, negotiation, and leadership skills
- •Ability to travel
- •Ability to manage stress
- •Professional, trustworthy, and disciplined
- •Ability to problem-solve unstructured challenges
- •Strong command of English, both written and verbal
- •Strong command of local language, both written and verbal
- •Excellent communication and interpersonal skills
- •Good computer skills with clinical trial management systems
- •Self-starter who thrives in a collaborative environment
- •Knowledge of clinical research, ICH GCP, and local regulations
- •Knowledge of regulatory and ethical requirements
- •Ability to establish and maintain positive relationships
- •Permanent authorization to work in the U.S.
- •Certified Monitor in compliance with Italian CRO decree
- •Graduation in a scientific health field
- •Adequate English
- •Bachelor of Science in Biology, Biotechnology, Life Sciences, or Pharmacy
Bachelor-Abschluss
Berufserfahrung
3 Jahre
Deine Aufgaben
- •Provide guidance and oversight to the CRA team
- •Review monitoring visit reports
- •Conduct co-monitoring and evaluation visits
- •Ensure timely investigator site visits
- •Coordinate with cross-functional departments for issue resolution
- •Assist in developing study-specific Monitoring Plans
- •Create training presentations as needed
- •Set up and collect site-specific ethics documents
- •Negotiate site contracts as required
- •Provide monthly billing information to the finance team
- •Manage study budget for stand-alone projects
- •Perform qualification, initiation, interim, and close-out visits
- •Document monitoring visits accurately and timely
- •Ensure integrity of CRF data through source document review
- •Conduct quality control of documents for eTMF/TMF
- •Account for investigational product
- •Review site regulatory binder for required documents
- •Maintain regular contact with study sites for compliance
- •Assess patient accrual rates and respond to sponsor requests
- •Ensure compliance with ICH GCP guidelines and FDA regulations
- •Participate in internal and client meetings as required
- •Facilitate adverse event reporting and reconcile SAE reports
- •Resolve queries on discrepant data with in-house CRAs
- •Identify site issues and develop problem-solving strategies
- •Prepare for audits at study sites as needed
- •Collaborate with other CRAs to promote team consistency
- •Assist in CRA new hire training and onboarding
- •Mentor junior CRAs
- •Collaborate on the development of the Clinical Trial Management System
- •Manage conflicting priorities to meet commitments
- •Perform additional duties as assigned
Tools & Technologien
clinical trial management systemsclinical trial databaseselectronic data capture
Sprachen
Englisch – verhandlungssicher
LOCAL – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Alira Health 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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