Senior CRA I/II - FSP

🕒 2 days ago

🇦🇺 Australia – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 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 • Verify informed consent processes, subject/patient confidentiality, safety, and clinical data integrity • Assess site processes and conduct source document review of site documents and medical records • Verify clinical data entered in case report forms is accurate and complete • Resolve queries remotely and on site within agreed timelines • Use hardware and software for clinical study data review and capture and verify electronic data capture compliance • Manage investigational product inventory, reconciliation, storage, dispensing, administration, and accountability as applicable • Review Investigator Site Files and reconcile them with Trial Master Files • Document monitoring activities through letters, trip reports, communication logs, and other project documents • Support subject/patient recruitment, retention, and awareness strategies • Track observations, ongoing status, and action items to resolution • Manage site-level activities and communications to meet project objectives, deliverables, and timelines • Serve as liaison with study site personnel and ensure site team training and compliance • Prepare for and attend investigator and sponsor meetings and participate in clinical monitoring/project staff meetings • Support audit readiness, audit preparation, and follow-up actions • Provide supervision, training, and mentorship to junior CRAs • For Real World Late Phase studies, support sites throughout the study lifecycle, perform chart abstraction and data collection, develop informed consent forms, support regulatory activities, contribute to RFPs and budgeting, develop site management strategies, and participate in case report form and edit check development

🎯 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 • Working knowledge of ICH/GCP Guidelines, Good Pharmacoepidemiology Practices (GPP), relevant regulations, and company SOPs/processes • Familiarity with clinical monitoring, site management, regulatory compliance, and clinical trial documentation

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition • Total rewards program • Inclusive culture • Opportunity to collaborate with colleagues across the world

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