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CRA II/Sr CRA - Oncology

🔥 0 minutes ago

🌲 Oregon – Remote

infoinfo

⏰ Full Time

🟠 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 0 minutes ago

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 and close-out visits on-site or remotely • Ensure regulatory, ICH-GCP/GPP and protocol compliance • Evaluate site and site staff performance and develop or escalate action plans • Verify informed consent, subject/patient safety and clinical data integrity • Assess site processes and conduct source document review and medical record review • Verify clinical data in case report forms and drive query resolution to closure • Support clinical study data review, capture and electronic data capture compliance • Perform investigational product inventory, reconciliation, storage, dispensing and administration reviews • 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, status and action items through resolution • Manage site-level activities and communications against project scope, budgets, timelines and deliverables • Liaise with study site personnel and train assigned site/project team members • Attend investigator meetings, sponsor meetings, global project meetings and clinical training • Support audit readiness, audit preparation and follow-up actions • For Real World Late Phase: support sites throughout the study lifecycle, conduct 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 • Must comply with site requests for medical and other personal information required for facility access as a condition of employment • For Real World Late Phase: knowledge of local requirements for real world late phase study designs • For Real World Late Phase: chart abstraction activities and data collection experience/knowledge • For Real World Late Phase: collaboration with Sponsor affiliates, medical science liaisons and local country staff

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition and total rewards program • Company car or car allowance • Medical, Dental and Vision health benefits • Company match 401k • Eligibility to earn commissions/bonus based on company and individual performance • Flexible paid time off (PTO) • Sick time

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