CRA II / Snr CRA I – Multi Sponsor

🕒 il y a 10 jours

🇬🇧 Royaume-Uni – Télétravail

⏰ Temps Plein

🟡 Intermédiaire

🟠 Senior

🧪 Chercheur Clinique

🗣️🇺🇸🇬🇧 Anglais requis

D'où vient cette offre

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

Repérée par Remote Rocketship il y a 10 jours

Toujours ouverte sur le site de Syneos Health. Vérifiée il y a 1 heure.

Logo of Syneos Health

Syneos Health

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 activities and close-out visits, on-site or remotely • Ensure regulatory, ICH-GCP/GPP and protocol compliance • Evaluate site and site staff performance and recommend site-specific actions • Communicate and escalate serious issues and develop action plans • Verify informed consent processes and documentation • Assess subject/patient safety, clinical data integrity, protocol deviations and pharmacovigilance issues • Assess site processes for Clinical Monitoring/Site Management Plans • Conduct source document reviews and medical record reviews • Verify clinical data entered in case report forms is accurate and complete • Resolve queries remotely and on site within agreed timelines • Use hardware and software for clinical project data review and capture • Verify electronic data capture compliance • Manage investigational product inventory, reconciliation, storage, dispensing and administration as applicable • Review Investigator Site Files and reconcile them with Trial Master Files • Document activities through letters, trip reports, communication logs and other project documents • Support subject/patient recruitment, retention and awareness strategies • Track observations, status and action items to resolution • Manage site-level activities and communications to meet project objectives, deliverables and timelines • Act as liaison with project site personnel and ensure assigned sites and team members are trained and compliant • Attend Investigator Meetings, sponsor meetings, global monitoring meetings and clinical training sessions • Support audit readiness and audit preparation and follow-up actions • For Real World Late Phase: support sites throughout the study lifecycle, perform chart abstraction and data collection, and collaborate with sponsor affiliates, medical science liaisons and local country staff

🎯 Exigences

• Bachelor’s degree or RN in a related field, or equivalent combination of education, training and experience • 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 • Ability to manage required travel of up to 75% on a regular basis

🏖️ Avantages

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Inclusive culture • Reasonable accommodations when appropriate

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