Senior CRA I/II – FSP

🔥 6 minutes ago

🇦🇺 Australia – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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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 • Ensure regulatory, ICH-GCP/GPP and protocol compliance • Verify informed consent processes, subject/patient confidentiality, safety and clinical data integrity • Conduct source document review and verify clinical data in case report forms • Resolve queries remotely and on site within agreed timelines • Support clinical study data review, capture and electronic data capture compliance • Manage investigational product inventory, reconciliation, storage, security, dispensing and returns • Review Investigator Site Files and reconcile them with Trial Master Files • Document monitoring activities and track observations, status and action items • Support subject/patient recruitment, retention and awareness strategies • Manage site-level activities, communications, budgets and timelines • Liaise with study site personnel and ensure assigned sites and project staff are trained and compliant • Prepare for and attend investigator and sponsor meetings and participate in clinical monitoring meetings • Support audit readiness and audit follow-up actions • Provide supervision, training and mentorship to junior CRAs • For RWLP, support sites throughout the study lifecycle, perform chart abstraction and data collection, develop informed consent forms, contribute to RFPs and budgeting, develop site management strategies, and support regulatory and case report form activities

🎯 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 • Moderate level of critical thinking skills • Ability to manage required travel of up to 75% on a regular basis

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Inclusive culture • Reasonable accommodations when appropriate

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