Senior Clinical Research Associate, Germany

🕒 il y a 1 mois

🇩🇪 Allemagne – Télétravail

⏰ Temps Plein

🟠 Senior

🧪 Chercheur Clinique

🗣️🇺🇸🇬🇧 Anglais requis

D'où vient cette offre

Publiée sur la page carrières de Alimentiv, pas via un site d'emploi

Repérée par Remote Rocketship il y a 1 mois

Toujours ouverte sur le site de Alimentiv. Vérifiée il y a 10 heures.

Logo of Alimentiv

Alimentiv

201 - 500 employés

Fondée en 2020

🏥 Santé

💼 Conseil

📦 Logistique

Healthcare • Consulting • Logistics

Alimentiv est une organisation de recherche sous contrat spécialisée dans les maladies gastro-intestinales (GI) et hépatiques. Avec plus de 30 ans d'expérience, Alimentiv offre une gamme complète de services de recherche clinique et d'imagerie, incluant la gestion d'essais cliniques, la gestion de sites, les affaires réglementaires et la médecine de précision. L'entreprise est à la pointe de la recherche et du développement médical, offrant des solutions d'imagerie de pointe et des analyses de biomarqueurs exploitables. Alimentiv soutient le développement de composés GI et est active dans plus de 60 pays, travaillant avec un réseau d'experts médicaux et opérationnels pour accélérer les essais cliniques et le recrutement de patients.

Description

• Independently perform, coordinate, and oversee clinical site monitoring services • Assess protocol and regulatory compliance according to company and sponsor processes, ICH/GCP guidelines, and local regulations • Serve as the primary liaison between the sponsor/Alimentiv and investigative sites • Execute clinical study plans • Conduct and document onsite and remote monitoring, close-out, qualification, and initiation visits • Review study data against source documents and resolve or escalate data queries • Coordinate shipment and delivery of investigational products, laboratory supplies, ePROs, and study documents • Train site staff on protocols, study plans, systems, and ICH-GCP • Review ISF and TMF for accuracy, timeliness, and completeness • Act as primary contact for investigational site questions and issues • Support site activation, recruitment milestones, study communications, and project timelines • Participate in study meetings, investigator meetings, audits, and inspections • Mentor CRA I and II and perform CRA assessment or co-monitoring visits • Support hiring interviews and process improvement initiatives

🎯 Exigences

• 4–6 years of related experience • (Honors) Bachelor’s degree • Fluent in written and verbal English • An equivalent combination of education and experience may be considered • Thorough knowledge of ICH-GCP and local regulatory requirements • Proficiency with EDC systems such as Medidata Rave and Oracle InForm, IRT, eTMF, CTMS, and Microsoft Office Suite • Ability to travel up to 40–60%, depending on project assignment and site geography • Health Sciences, Life Sciences, Pharmacy, or Nursing degree preferred, or Sr. CRA and/or ACRP Certification/Designation • Experience with Phase I–IV clinical trials preferred • Valid driver’s license • Strong interpersonal and problem-solving skills • Ability to work independently and within cross-functional teams • Strong communication and organizational skills, attention to detail, and sense of urgency

🏖️ Avantages

• Full-time, permanent employment • Home-based work arrangement • Regular travel required • Opportunity to mentor and support CRA I and II • Participation in process improvement initiatives and development of best practices

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