Senior CRA I / Senior CRA II – Sponsor Dedicated

🕒 3 days ago

🇪🇸 Spain – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 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 recommend site-specific actions • Escalate serious issues and develop action plans • Verify informed consent processes, patient confidentiality, safety and clinical data integrity • Conduct source document review and verify clinical data accuracy and completeness • Resolve queries remotely and on site within agreed timelines • Support clinical study data review, capture and electronic data capture compliance • Manage investigational product inventory, reconciliation, storage, security and dispensing compliance • Review and reconcile Investigator Site Files and Trial Master Files • Document monitoring activities and maintain tracking systems • Support subject/patient recruitment, retention and awareness strategies • Manage site-level activities and communications to meet project objectives, deliverables and timelines • Liaise with project site personnel and ensure assigned sites and staff are trained and compliant • Attend investigator, sponsor and clinical training meetings • Support audit readiness and audit follow-up actions • Provide training and mentorship to junior CRAs • Perform site support throughout the study lifecycle, chart abstraction and data collection for Real World Late Phase studies • Collaborate with sponsors, affiliates, medical science liaisons and local country staff • Identify out-of-scope activities, potential sites, operational efficiencies and process improvements • Develop country-level informed consent forms • Collaborate with the RWLP Regulatory team • Participate in bid defense meetings

🎯 Requirements

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience • Minimum of 5+ years of experience in the pharmaceutical / biotechnology industry monitoring as a Clinical Research • 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

🏖️ Benefits

• 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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