Clinical Research Associate II
9 hours ago
The Clinical Research Associate II (CRA II) plays a pivotal role in the successful execution of Oncology and Hematology clinical trials within the country. As a key member of the clinical team, the CRA II is responsible for delivering high-quality data within established timelines, ensuring adherence to monitoring procedures in accordance with GCP, ICH, local regulations, and SOPs.
Key Responsibilities:- Conducts monitoring activities, including pre-study, initiation, routine monitoring, and closeout visits, as required.
- Ensures study milestones for assigned sites are met as planned, including study startup, recruitment, database analysis, and closeout.
- Attends onboarding, disease indication, and project-specific training, as well as general CRA training, as required.
- Documents monitoring activities accurately, following ICH-GCP and BeiGene standards.
- Conducts Quality Oversight Visits (QOVs), as requested, and completes monitoring visit/QOV reports in a timely manner.
- Assists with investigator/site identification, prepares Ethics Committee submissions, and facilitates clinical trial site contract and budget negotiations.
- Manages site queries and communications, and assists in managing clinical trials, as required.
- Establishes regular lines of communication with sites and Clinical Operations Managers (COMs).
- Provides protocol and related study training to assigned sites and evaluates the quality and integrity of site practices, escalating quality issues as necessary.
- Manages site performance by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution.
- Collaborates with the CRA Group/CRM to ensure recruitment plans are executed and contingency plans are implemented, as needed.
- Bachelor's level degree or above in life sciences, pharmacy, nursing, or medicine.
- Thorough understanding of clinical trial processes and knowledge of ICH and associated regulatory guidelines.
- At least 1 year of monitoring experience in the pharmaceutical or CRO industry (over 4 years for SCRA).
- Excellent communication and interpersonal skills.
- Excellent organizational skills and ability to prioritize and multi-task.
- Fluent in English (writing and speaking).
- Must have full Australian working rights to be considered.
- Market-competitive compensation package, including a performance-based annual bonus scheme.
- Company shares, including a generous welcome grant and performance-based annual equity plan.
- In-house and external learning and development opportunities.
- Fantastic benefits program and ongoing improvements.
- The opportunity to work with a dynamic team of collaborative, supportive, inclusive, and fun professionals who share a clear mission: Cancer has no borders, and neither do we.
When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity, and Driving Excellence through our twelve global competencies, we help bring more affordable medicines to patients worldwide.
- Fosters Teamwork
- Provides and Solicits Honest and Actionable Feedback
- Self-Awareness
- Acts Inclusively
- Demonstrates Initiative
- Entrepreneurial Mindset
- Continuous Learning
- Embraces Change
- Results-Oriented
- Analytical Thinking/Data Analysis
- Financial Excellence
- Communicates with Clarity
BeiGene is committed to respecting and protecting the personal information rights of job applicants and will process job applicants' personal information in accordance with applicable laws and regulations.
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