Job Summary: We are seeking an experienced Senior Clinical Research Associate (SrCRA) to join our team and support monitoring and site management for client-sponsored oncology studies. Your expertise will ensure compliance with ICH GCP, local regulations, and client SOPs while fostering effective collaboration with clinical study teams and investigator site personnel.

Key Responsibilities:
• Site Management and Monitoring Activities: Conduct site qualification, initiation, interim, and close-out visits both on-site and remotely, ensuring adherence to protocols and regulatory requirements.
• Partner with Clinical Trial Liaison (CTL) and various functions to facilitate site activation and meet study deliverables.
• Maintain professional relationships with site staff, promoting effective communication and problem-solving throughout the study.
• Perform drug accountability and ensure compliance with storage and shipment protocols.
• Oversight Monitoring: Develop and maintain an Oversight Monitoring Plan, review CRO CRA and site performance, and identify sites for oversight visits.
• Conduct oversight monitoring visits, review site documentation, and ensure accurate data capture.
• Documentation and Reporting: Keep site regulatory files updated, verify timely submission of study documentation, and submit accurate monitoring reports promptly.
• Issue Management and Escalation: Identify protocol deviations, track and trend issues, and escalate them to appropriate teams as necessary.
• Collaboration and Communication: Engage in ongoing communication with site personnel and study teams, participate actively in meetings, and contribute to process improvements.
• Inspection Readiness: Support inspection readiness activities, ensuring data integrity and protocol compliance at sites.

Job Requirements:
• Education: Bachelor's degree (or equivalent)
• Experience: A minimum of 5 years of direct onsite monitoring/CRA experience, with required Phase I oncology monitoring expertise.
• Strong analytical skills and a working knowledge of the clinical drug development process.
• Skills: Effective communication and interpersonal skills, familiarity with medical terminology, and proficiency in IT applications including Microsoft Office, EDC, CTMS.
• Excellent prioritization, time management skills, and the ability to deliver clear written reports.

EEO Disclaimer: Our organization is an equal opportunity employer. We welcome applications from individuals regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.