Senior Clinical Research Associate

🕒 il y a 2 mois

🇳🇱 Pays-Bas – Télétravail

⏰ Temps Plein

🟠 Senior

🧪 Chercheur Clinique

👻 Score fantôme 27%

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 62 jours.
• Les offres de cette entreprise sont généralement pourvues en 26 jours.
• Aucun salaire indiqué.

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Thermo Fisher Scientific

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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 • Conduct remote and on-site visits to assess protocol and regulatory compliance • Manage required documentation, procedures, and sponsor or monitoring-environment guidelines • Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs • Monitor investigator sites using a risk-based monitoring approach • Apply root cause analysis, critical thinking, and problem-solving to identify failures and implement corrective/preventive actions • Ensure data accuracy through source data review, source data verification, and CRF review • Assess investigational product inventory and records • Document observations in timely reports and letters; escalate and resolve deficiencies • Maintain contact with investigative sites between monitoring visits • Conduct monitoring tasks according to approved monitoring plans • Participate in investigator payment processes and findings resolution • Track trial status and provide progress updates to the Clinical Team Manager • Update and quality-check clinical trial management systems and reports • Participate in investigator meetings and identify qualified investigators and sites • Initiate clinical trial sites and make compliance recommendations • Ensure trial closeout and retrieval of trial materials • Maintain complete essential documents and conduct on-site file reviews • Support project publications, tools, newsletters, trip report reviews, and CRA team calls • Facilitate communication among investigative sites, client companies, and the project team • Respond to company, client, regulatory requirements, audits, and inspections • Complete expense reports and timesheets • Contribute to process improvement initiatives and other assigned project work

🎯 Exigences

• Bachelor's degree in a life sciences related field, or Registered Nursing certification, or equivalent relevant formal academic/vocational qualification • Equivalent combination of appropriate education, training and/or directly related experience may be considered • 2+ years of experience as a clinical research monitor • Valid driver's licence where applicable • Effective clinical monitoring skills • Understanding of medical/therapeutic area knowledge and medical terminology • Demonstrated 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 • Effective interpersonal skills and strong attention to detail • Organizational and time management skills • Flexibility and adaptability • Ability to work independently and in a team • Proficient knowledge of Microsoft Office and ability to learn appropriate software • Fluency in Dutch and English • Good presentation skills • Ability to comply with specific sponsor/client/site requirements • Willingness and ability to travel frequently, generally 60–80%, including frequent drives to site locations and possible overnight stays • Ability to work in office, laboratory, clinical, and/or home office environments and handle required personal protective equipment

🏖️ Avantages

• Fully remote work option anywhere in The Netherlands • Hybrid or office-based work options • Standard Monday–Friday work schedule

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