Sponsor Dedicated CRA II/Sr CRA I/II

🕒 il y a 2 mois

🇮🇹 Italie – Télétravail

💵 €45 000 - €69 000 / an

⏰ Temps Plein

🟠 Senior

🧪 Chercheur Clinique

👻 Score fantôme 35%

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 86 jours.
• Les offres de cette entreprise sont généralement pourvues en 21 jours.

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Syneos Health

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10 000+ employés

🏥 Santé

💼 Conseil

📦 Logistique

Healthcare • Consulting • Logistics

Syneos Health est une organisation de solutions biopharmaceutiques entièrement intégrée et leader, conçue pour accélérer le succès des clients. Ils transforment des intuitions cliniques, des affaires médicales et commerciales uniques en résultats pour répondre aux réalités du marché moderne. En utilisant des technologies avancées et des perspectives, Syneos Health collabore avec les clients pour accélérer la livraison de thérapies importantes aux patients dans le monde entier, offrant des services qui couvrent tout le spectre du clinique au commercial.

Description

• Perform site qualification, site initiation, interim monitoring, site management and close-out visits on-site or remotely • Evaluate site and site staff performance and provide recommendations or site-specific action plans • Escalate serious issues to the project team • Verify informed consent, subject/patient confidentiality, safety and clinical data integrity • Assess site processes and conduct source document review • Verify clinical data in case report forms against source documents and medical records • Resolve queries remotely and on site and guide site staff toward closure • Support clinical study data review and capture using hardware and software • Verify compliance with electronic data capture requirements • Manage investigational product inventory, reconciliation, storage, dispensing and administration when applicable • Review Investigator Site Files and reconcile them with Trial Master Files • Document monitoring activities through required letters, reports and communication logs • Support subject/patient recruitment, retention and awareness strategies • Track observations, site status and action items to resolution • Manage site-level activities and communication to meet project objectives, deliverables and timelines • Liaise with project site personnel and ensure assigned sites and team members are trained and compliant • Attend Investigator Meetings, sponsor meetings, clinical monitoring/project staff meetings and training sessions • Support audit readiness and preparation for audits and follow-up actions • Provide training or mentorship to junior CRAs and perform training/sign-off visits when assigned • Perform clinical operations lead tasks under supervision when assigned

🎯 Exigences

• At least 2,5 yrs of experience as Certified CRA according to DM 15 Nov 2011 • Oncology monitoring experience and phase I experience preferred • Experience with Risk Based Monitoring is a plus • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements • Good computer skills and ability to embrace new technologies • Excellent communication, presentation and interpersonal skills • Basic level of critical thinking skills • Ability to manage required travel of up to 75% on a regular basis • Equivalent experience, skills, and/or education may be considered

🏖️ Avantages

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition and total rewards program • Total Self culture • Diversity, inclusion and belonging initiatives • Additional benefits and allowances (not specified)

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