Clinical Research Associate

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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 staff performance and recommend site-specific actions • Escalate serious issues to the project team and develop action plans • Verify informed consent, subject/patient confidentiality, safety, and clinical data integrity • Assess site processes and conduct source document review • Verify clinical data entered in case report forms is accurate and complete • Resolve queries remotely and on site within agreed timelines • Support clinical study data review and capture using available hardware and software • Verify electronic data capture compliance • Manage investigational product inventory, reconciliation, storage, dispensing, administration, labeling, import, and release/return as applicable • Review and reconcile Investigator Site Files with Trial Master Files • Document monitoring activities through required project documents • Support subject/patient recruitment, retention, and awareness strategies • Track observations, status, and action items to resolution • Manage site-level activities, communications, scope, budgets, and timelines • Liaise with study site personnel and Central Monitoring Associates • Ensure assigned sites and project team members are trained and compliant • Attend Investigator Meetings, sponsor meetings, global monitoring meetings, and clinical training • Support audit readiness, audit preparation, and follow-up actions • For Real World Late Phase, provide site support across 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 based on local knowledge

🎯 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 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 complete assigned training as required • Must understand local requirements for real world late phase study designs, where applicable

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition and total rewards program • Inclusive culture • Comprehensive resources including emerging technologies, data, science and knowledge sharing • Exposure to career paths and employment opportunities across a growing, global company • Reasonable accommodations when appropriate