CRA II – SCRA I
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Job Description
Clinical Research Associate monitoring clinical trial sites for Syneos Health, a life sciences services organization. Ensuring GCP compliance, data integrity, site management and audit readiness across Australia.
Responsibilities:
- Perform site qualification, site initiation, interim monitoring, site management and close-out visits on-site or remotely
- Ensure regulatory, ICH-GCP/GPP and protocol compliance
- Evaluate site and site staff performance and provide recommendations or escalate serious issues
- Verify informed consent processes, subject/patient confidentiality, safety and clinical data integrity
- Assess site processes and conduct source document review
- Verify clinical data entered in case report forms against source documents and medical records
- Resolve queries remotely and on site within agreed timelines
- Use hardware and software for clinical study data review and capture
- Verify electronic data capture compliance
- Perform investigational product inventory, reconciliation, storage, security and dispensing reviews as applicable
- Review Investigator Site Files and reconcile them with Trial Master Files
- Document monitoring activities and maintain tracking systems
- Support subject/patient recruitment, retention and awareness strategies
- Manage site-level activities and communications to meet project objectives, deliverables and timelines
- Liaise with project site personnel and ensure site team training and compliance
- Prepare for and attend Investigator and sponsor meetings
- Participate in or lead clinical monitoring/project staff meetings and attend clinical training
- Support audit readiness and audit follow-up actions
- Provide training or mentorship to junior CRAs and perform training/sign-off visits as assigned
- For RWLP: support sites throughout the study lifecycle, perform chart abstraction and data collection, develop country-level informed consent forms, collaborate with regulatory teams, identify operational efficiencies, participate in bid defense meetings 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
- Basic 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, for employees or applicants with disabilities
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