Qualifications

• 2-3+ years of Clinical Research Associate experience preferred.
• Prior onsite monitoring experience is required.
• Strong Oncology clinical research experience required; deep Oncology CRA experience is strongly preferred.
• Experience with site initiation activities is preferred.
• Strong knowledge of FDA regulations, ICH GCP, and applicable local regulations is essential.
• Direct experience working with investigative sites and study teams is necessary.
• Strong communication, organizational, and relationship-management skills.
• Candidates transitioning from a Clinical Research Coordinator role into an Oncology CRA/monitoring position may be considered.
• Bachelor's degree or equivalent experience required.

Responsibilities

• Develop and maintain relationships with investigative sites and client personnel.
• Conduct onsite monitoring visits to ensure study compliance with protocols and regulations.
• Monitor sites for accuracy and completeness of patient records and study data.
• Support site initiation and ongoing management throughout clinical trials.
• Provide trial status updates and progress reports to the Trial Manager and client.
• Manage study data and documentation in line with regulatory requirements.
• Ensure compliance with applicable SOPs and regulations at sites.
• Assist with audit preparation and participation during regulatory inspections.
• Identify and resolve site-level issues and study-related challenges.
• Travel regionally to assigned investigative sites as required.

Benefits

• Paid holidays
• Regional travel
• Per diem for travel
• Internet allowance for travel
• Opportunity for professional advancement
• Support of one dedicated pharmaceutical sponsor