Senior Clinical Research Associate, UK Monitoring Experience

🕒 il y a 1 jour

🇬🇧 Royaume-Uni – Télétravail

⏰ Temps Plein

🟠 Senior

🧪 Chercheur Clinique

🇬🇧 Parrain de Visa de Travailleur Qualifié UK

Cette entreprise a parrainé des visas de Travailleur Qualifié du Royaume-Uni par le passé.

👻 Score fantôme 10%

Ce que ça veut dire : la probabilité que cette offre reste ouverte sans recrutement actif.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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Syneos Health

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10 000+ employés

🏥 Santé

💼 Conseil

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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 • Ensure regulatory, ICH-GCP/GPP and protocol compliance • Evaluate site and site staff performance and provide recommendations and action plans • Verify informed consent processes, subject/patient confidentiality, safety and clinical data integrity • Assess site processes and conduct source document review and medical record review • Verify clinical data entered in case report forms and resolve queries within agreed timelines • Use hardware and software to support clinical study data review and capture • Verify compliance with electronic data capture requirements • Perform investigational product inventory, reconciliation, storage, dispensing and administration checks as applicable • Review Investigator Site Files and reconcile them with Trial Master Files • Document monitoring activities through letters, trip reports, communication logs and 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 • Liaise with project site personnel and Central Monitoring Associates • Ensure assigned sites and project-specific site team members are trained and compliant • Prepare for and attend Investigator Meetings, sponsor meetings, clinical monitoring/project staff meetings and training sessions • Support audit readiness, audit preparation and follow-up actions • Provide training or mentorship to junior CRAs and perform training/sign-off visits as assigned • For RWLP: support sites throughout the study lifecycle, perform chart abstraction and data collection, develop country-level informed consent forms, identify operational efficiencies, participate in bid defense meetings and collaborate with sponsors, affiliates, regulatory teams, 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 • Basic level of critical thinking skills • Ability to manage required travel of up to 75% on a regular basis • UK monitoring experience • Working knowledge of ICH/GCP Guidelines, Good Pharmacoepidemiology Practice (GPP), relevant regulations, and company SOPs/processes • Ability to perform clinical monitoring activities on-site or remotely • Ability to manage site-level activities, communications, project objectives, deliverables and timelines • Ability to quickly adapt to changing priorities

🏖️ 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, to assist employees or applicants with disabilities