Clinical Research Associate, Level I

🕒 il y a 27 jours

🇳🇱 Pays-Bas – Télétravail

⏰ Temps Plein

🟢 Junior

🟡 Intermédiaire

🧪 Chercheur Clinique

👻 Score fantôme 21%

Ce que ça veut dire : la probabilité que personne ne recrute vraiment pour cette offre.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Pourquoi ce score :

• Ouverte depuis 27 jours.
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• Republiée une fois.
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Thermo Fisher Scientific

Site WebLinkedInTous les Emplois

10 000+ employés

Fondée en 1956

🏥 Santé

📦 Logistique

🏭 Fabrication

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific est le leader mondial dans le service aux sciences, avec un chiffre d'affaires annuel de plus de 40 milliards de dollars. Leur mission est de permettre à leurs clients de rendre le monde plus sain, plus propre et plus sûr en soutenant la recherche en sciences de la vie, en résolvant des défis analytiques complexes, en augmentant la productivité des laboratoires et en améliorant la santé des patients grâce aux diagnostics et au développement de thérapies révolutionnaires. Avec une équipe mondiale, ils offrent des technologies innovantes et des services pharmaceutiques à travers des marques telles que Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon et PPD.

Description

• Perform and coordinate clinical monitoring and site management activities for a client-dedicated FSP team • Conduct remote and on-site investigator site visits to assess protocol and regulatory compliance • Manage sponsor-specific procedures and guidelines • Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations and SOPs • Ensure audit readiness and develop collaborative relationships with investigative sites • Apply risk-based monitoring, root cause analysis and corrective/preventive actions • Ensure data accuracy through source document review, source data verification and CRF review • Assess investigational product inventory and records • Document observations in reports and letters and escalate deficiencies through resolution • Maintain contact with investigative sites between monitoring visits • Conduct monitoring tasks according to the approved monitoring plan • Participate in investigator payment processes and investigator meetings • Track trial status, provide progress updates to the Clinical Team Manager and update study systems such as CTMS • Perform CTMS report quality-control checks when required • Identify potential investigators and initiate clinical trial sites • Ensure trial closeout and retrieval of trial materials • Ensure essential documents are complete and conduct on-site file reviews • Assist with project publications, tools and other study tasks • Facilitate communication among investigative sites, the client company and the PPD project team • Respond to company, client and regulatory requirements, audits and inspections • Complete expense reports and timesheets • Contribute to project work and process-improvement initiatives

🎯 Exigences

• Bachelor's degree in a life sciences related field or Registered Nursing certification or equivalent and relevant formal academic / vocational qualification • 6 months–1 year of experience as a clinical research monitor, or comparable experience providing the required knowledge, skills, and abilities • Valid full driver's licence • Equivalency may be considered through a combination of appropriate education, training and/or directly related experience • Effective clinical monitoring skills • Understanding of medical/therapeutic area knowledge and medical terminology • Understanding and application of ICH GCPs, applicable regulations and procedural documents • Critical thinking, root cause analysis and problem-solving skills • Ability to manage Risk Based Monitoring concepts and processes • Effective oral and written communication skills, including communication with medical personnel • Customer focus, listening skills, attention to detail and ability to perceive underlying issues • Effective interpersonal, organizational and time management skills • Flexibility and adaptability • Ability to work independently and in a team • Proficiency in Microsoft Office and ability to learn appropriate software • Good Dutch, French and English language and grammar skills • Good presentation skills

🏖️ Avantages

• Fully Remote work arrangement • Standard Monday–Friday work schedule

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