CRA II/Sr CRA – Ophthalmology

🔥 0 minutes ago

⛷️ Utah – Remote

⛷️ Utah – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 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 and close-out visits, on-site or remotely • Evaluate site and site staff performance and provide site-specific recommendations and action plans • Ensure regulatory, ICH-GCP/GPP and protocol compliance • Verify informed consent processes, subject/patient safety and clinical data integrity • Conduct source document review and medical record review • Verify clinical data entered in case report forms and resolve queries • Verify electronic data capture compliance • Manage investigational product inventory, reconciliation, storage, dispensing and administration when 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, communications, deliverables, budgets and timelines • Liaise with study site personnel and Central Monitoring Associates • Train assigned sites and project-specific site team members • Attend investigator, sponsor and global clinical monitoring meetings and clinical training • 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 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 • For US employment, required compliance with site requests for medical and other personal information needed for facility access

🏖️ 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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