CRA I, no monitoring experience required

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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 recommendations and action plans • Maintain knowledge of ICH/GCP guidelines, applicable regulations, and company SOPs/processes • Verify informed consent, confidentiality, subject safety, clinical data integrity, and protocol compliance • Assess site processes and conduct source document review of site source documents and medical records • Verify clinical data entered in case report forms is accurate and complete • Apply query resolution techniques and drive query resolution to closure within agreed timelines • Use hardware and software for clinical project data review and capture • Verify compliance with electronic data capture requirements • Perform investigational product inventory, reconciliation, storage, dispensing, administration, labelling, import, and return reviews as applicable • Review Investigator Site Files and reconcile them with the Trial Master File • Ensure essential documents are archived according to local guidelines and regulations • Document activities through confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents • Support subject/patient recruitment, retention, and awareness strategies • Track observations, ongoing status, and action items through tracking systems • Manage site-level activities and communications to meet project objectives, deliverables, budgets, and timelines • Act as liaison with project site personnel, independently or with another CRA or Central Monitoring Associate • Ensure assigned sites and project-specific site team members are trained and compliant • Prepare for and 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, support the study lifecycle from site identification through close-out, chart abstraction, data collection, and collaboration with sponsor affiliates, medical science liaisons, and local country staff

🎯 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 Real World Late Phase: knowledge of local requirements for real world late phase study designs • For Real World Late Phase: chart abstraction and data collection capabilities • Ability to adapt to changing priorities under the oversight of the Lead CRA • Ability to ensure assigned sites and project-specific site team members are trained and compliant with applicable requirements

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Total Self culture • Diversity, inclusion, and belonging initiatives • Comprehensive resources including emerging technologies, data, science and knowledge sharing • Reasonable accommodations, when appropriate