Senior Oncology Clinical Research Associate

2 days ago

Melbourne, Victoria, Australia Pharmiweb Full time
Job Title: Senior Oncology Clinical Research Associate

About the Job:
We are seeking an experienced Senior Oncology Clinical Research Associate to join our team at Pharmiweb. The successful candidate will be responsible for ensuring the integrity of clinical data and compliance with regulations in oncology monitoring.

Key Responsibilities:
• Conduct site visits and monitor clinical trials in accordance with the Study Monitoring Plan (SMP) and local regulations.
• Collaborate with Site Managers to ensure sites comply with protocols and are inspection-ready.
• Conduct source document review, verification of site source documents, and medical records.
• Verify required clinical data entered in the Case Report Form (CRF) is accurate and complete.
• Manage reporting of protocol deviations and follow-up actions.
• Perform Investigational Product (IP) inventory, reconciliation, and reviews storage and security.
• Ensure all activities are managed by site personnel who are appropriately delegated and trained.
• Enter data into tracking systems as required to track observations, status, and assigned action items to resolution.
• Review data entry timeliness, missing pages, outstanding data queries, and timelines for database locks.
• Check site and external facilities, equipment, and supplies continue to be adequate to conduct the trial.
• Collaborate with primary Site Manager and participate in global clinical monitoring and project staff meetings.

Requirements:
• 3+ years of experience in oncology monitoring.
• Excellent communication, presentation, and interpersonal skills.
• Ability to adapt to changing technologies and processes.
• Proficiency in English language required.
• Bachelor's degree or Registered Nurse (RN) in a related field or equivalent combination of education, training, and experience.

Benefits:
• Estimated annual salary: $65,000 - $85,000 depending on location and experience.
• Competitive benefits package including health insurance, retirement plan, and paid time off.
• Opportunities for professional growth and development in a dynamic and innovative company.

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