Senior CRA (Australia)

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Requirements:

• At least 2 years experience in Clinical Research Operations and onsite monitoring.
• Skills to mentor and train other CRAs in an effective manner.
• In-depth knowledge of clinical trials and critical success elements.
• Strong therapeutic background.
• Proven ability to manage people and project issues.
• Mature management skills with proactive problem identification.
• Ability to define and meet project requirements.
• Flexibility for improvement and creating solutions.
• Proven organizational abilities and excellent communication skills.
• Team player with strong customer focus.
• Thorough knowledge of regulatory submission and reporting requirements.
• Excellent understanding of the drug development process.

Responsibilities:

• Governs quality standards for trial monitoring activities.
• Performs Selection, Initiation, Monitoring and Closure Visits at Investigator Sites according to project schedule.
• Monitors activities at clinical study sites to assure adherence to GCP, ICH, SOPs, and study protocols.
• Tracks and supervises collection of ongoing study data for project status reporting.
• Collects and reviews regulatory documents as required.
• Prepares site visit reports and telephone contact reports.
• Maintains and updates CTMS in compliance with SOPs and study-specific directives.
• Acts as Document Owner for collected documents.
• Aims to pro-actively prevent and mitigate issues, resolving site issues including recruitment challenges.
• Acts as the main line of communication between the project team and the site staff.
• Collaborates with Allucent Centralized Monitoring Team to evaluate risk-based monitoring activities.
• Identifies potential logistical problems and supports project teams in creating solutions.
• Ensures continuous maintenance of the Trial Master File and Investigator Site File.
• Assists PM and CTL with generation of study specific forms and follow up.
• Works with PM, CTL, and SSU team members to ensure authorization of documents and contracts.
• Identifies documentation required for review by Regulatory Authorities and Ethical Committees.