CRA II

🕒 October 5

🇵🇱 Poland – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

Where this job comes from

Posted on Syneos Health's careers page, not through a job board

First seen by Remote Rocketship October 5

Logo of Syneos Health

Syneos Health

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 communicate or escalate serious issues • Verify informed consent, subject/patient confidentiality, safety and clinical data integrity • Assess site processes and conduct Source Document Review • Verify clinical data in case report forms and resolve queries remotely and on site • Support investigational product inventory, reconciliation, storage, dispensing and administration verification • 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, 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 assigned sites and project team members are trained and compliant • Attend investigator, sponsor, clinical monitoring and training meetings • Support audit readiness and audit follow-up actions • For Real World Late Phase, provide site support throughout the study lifecycle, perform chart abstraction and data collection, collaborate with sponsor affiliates and local staff, train junior staff, identify out-of-scope activities, and suggest potential sites

🎯 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 • Working knowledge of relevant regulations and company SOPs/processes • Ability to work with clinical monitoring, site management, electronic data capture, and clinical study documentation processes

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition and total rewards program • Inclusive culture • Collaborate with colleagues from across the world • Required training and clinical training sessions

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