Clinical Research Associate – Sponsor Dedicated

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⛰️ Colorado, Oregon – Remote

⛰️ Colorado – Remote 🌲 Oregon – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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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 recommend site-specific actions • Escalate serious issues and develop action plans • Verify informed consent processes, subject safety, confidentiality, protocol compliance, and clinical data integrity • Assess site processes and conduct source document review • Verify clinical data in case report forms and resolve queries • Verify electronic data capture compliance • Manage investigational product inventory, reconciliation, storage, dispensing, and administration as applicable • Review Investigator Site Files and reconcile them with Trial Master Files • Prepare confirmation letters, follow-up letters, trip reports, communication logs, and project documents • Support subject/patient recruitment, retention, and awareness strategies • Track observations, site status, and action items • Manage site-level activities and communications to meet project objectives, deliverables, budgets, and timelines • Act as liaison with study site personnel and collaborate with Central Monitoring Associates • Train assigned sites and project-specific site team members • Attend investigator, sponsor, clinical monitoring, project staff, and clinical training meetings • Support audit readiness and audit follow-up actions • For Real World Late Phase: support sites throughout the study lifecycle, perform chart abstraction and data collection, collaborate with sponsor affiliates, medical science liaisons, and local country 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 when required for facility access in the US • Working knowledge of company SOPs/processes • For Real World Late Phase: knowledge of local requirements for real world late phase study designs

🏖️ 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 401(k) • Eligibility to earn commissions/bonus based on company and individual performance • Flexible paid time off (PTO) • Sick time

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