CRA I – Sponsor-dedicated

🔥 42 minutes ago

🇵🇱 Poland – Remote

⏰ Full Time

🟡 Mid-level

🟠 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 activities 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 regarding site-specific actions • Escalate serious issues and develop action plans with guidance • Verify informed consent processes and protect subject/patient confidentiality • Assess subject/patient safety and clinical data integrity, including protocol deviations and pharmacovigilance issues • Assess site processes for the Clinical Monitoring/Site Management Plan • Conduct source document review and medical-record review • 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 site compliance with electronic data capture requirements • Perform investigational product inventory, reconciliation, storage and security reviews as applicable • Review Investigator Site Files and reconcile them with Trial Master Files • Document monitoring activities through required letters, reports, 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, CRAs or Central Monitoring Associates • Ensure assigned sites and project-specific site team members are trained and compliant • Prepare for and attend investigator and sponsor meetings and clinical training sessions • 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, and collaborate with sponsor affiliates, medical science liaisons and local country staff

🎯 Requirements

• 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

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Inclusive culture • Remote work arrangement (Remote (Pre-Approved))

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