Qualifications

• Undergraduate degree in clinical, science, or health-related field or equivalent; licensed health care professional preferred.
• Minimum of 5 years' experience in clinical monitoring, particularly in oncology Phase II/III.
• In-depth knowledge of ICH GCP guidelines and local regulatory requirements.
• Proficient in English (reading, writing, speaking).
• Experience in feasibility, site selection, and site startup activities required.
• Familiarity with budget negotiations preferred.
• Must have the ability to work independently as a Sr level CRA.

Responsibilities

• Implement and monitor clinical trials for compliance with regulatory requirements and GCP guidelines.
• Assess and qualify potential investigative sites, then initiate and close clinical trials at those sites.
• Manage site startup activities including regulatory documents, informed consent review, and budget negotiations.
• Verify accuracy of clinical trial data collected remotely or onsite.
• Provide regular updates and site status information to the clinical trial management team.
• Resolve site issues efficiently in collaboration with clinical team members.
• Perform essential document reconciliation and source document verification.

Benefits

• Comprehensive total rewards package supporting health and wellbeing.
• Health programs including medical, dental, and vision coverage when applicable.
• Retirement and pension plans offered.
• Life assurance and disability coverage available.
• Employee assistance programs and resources for wellbeing support.
• Opportunities for learning and development through structured training and career pathways.