
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.
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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.
• Perform site qualification, site initiation, interim monitoring, site management, and close-out visits on-site or remotely • Ensure regulatory, ICH-GCP/GPP, protocol, and company SOP/process compliance • Evaluate site and site staff performance and provide site-specific recommendations • Escalate serious issues and develop action plans • Verify informed consent, subject/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 • Verify electronic data capture compliance • Manage investigational product inventory, reconciliation, storage, security, dispensing, and administration as applicable • Review and reconcile Investigator Site Files 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, site status, and action items to resolution • Manage site-level activities and communications to meet project objectives, deliverables, budgets, and timelines • Act as liaison with study site personnel and ensure assigned sites and project team members are trained and compliant • Attend investigator, sponsor, global monitoring, and clinical training meetings • Support audit readiness, audit preparation, and follow-up actions • For Real World Late Phase: support sites throughout the study lifecycle, perform chart abstraction and data collection, collaborate with sponsor affiliates and local country staff, train junior staff, identify out-of-scope activities, and suggest potential sites
• 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 • Working knowledge of relevant regulations and company SOPs/processes • Ability to perform clinical monitoring and site management activities on-site or remotely • For Real World Late Phase: knowledge of local requirements for real world late phase study designs • For Real World Late Phase: chart abstraction and data collection experience/ability
• 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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🕒 October 20
Clinical Research Associate monitoring clinical studies for PSI CRO, a global medical research company. Conducting site visits, CRF review, source verification, and regulatory support in Latvia.