CRA II – Sponsor Dedicated

🔥 1 minute ago

🇪🇸 Spain – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

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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 provide recommendations and action plans • Ensure regulatory, ICH-GCP/GPP and protocol compliance • Verify informed consent processes and protect subject/patient confidentiality • Assess subject/patient safety, protocol deviations and pharmacovigilance issues • Conduct source document review and verify clinical data accuracy and completeness • Resolve queries remotely and on site within agreed timelines • Review investigational product inventory, storage, dispensing and administration as applicable • Review Investigator Site Files and reconcile them with the Trial Master File • Document monitoring activities through letters, reports, logs and project documents • Support subject/patient recruitment, retention and awareness strategies • Track observations, site status and action items to resolution • Manage site-level activities and communications to meet project objectives, deliverables and timelines • Act as liaison with study site personnel and ensure site team training and compliance • Prepare for and attend investigator, sponsor and clinical monitoring meetings and training sessions • Support audit readiness and audit follow-up actions • Support sites throughout the study lifecycle, including site identification through close-out • Perform chart abstraction and data collection for Real World Late Phase studies • Collaborate with sponsor affiliates, medical science liaisons and local country staff • Train junior staff when requested • Identify and communicate out-of-scope activities • Suggest potential sites based on local treatment patterns, patient advocacy and healthcare provider associations

🎯 Requirements

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience • 3-4 years of experience as CRA • Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements • Good computer skills and ability to embrace new technologies • Experience in Immunology, Cardiology, Pulmonary Hypertension, Ophthalmology or Lipids • Excellent communication, presentation and interpersonal skills

🏖️ 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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