Clinical Research Manager

Overview

• Lead clinical research operations for oncology trials, ensuring protocol adherence and regulatory compliance.
• Supervise Clinical Research Coordinators and Research Assistants across multiple satellite clinics.
• Manage study budgets, financial performance, and sponsor communications effectively.
• Ensure patient safety, ethical informed consent processes, and investigational product handling.
• Oversee data integrity, quality management, and compliance with regulatory standards.
• Contribute to strategic growth and process improvement initiatives for oncology research services.
• Support cross-site standardization and training for consistent operational excellence.
• Collaborate with stakeholders, including Principal Investigators and administrative leadership.

Key Responsibilities & Duties

• Provide operational leadership for oncology clinical trials, ensuring timely and compliant study conduct.
• Oversee protocol feasibility assessments, site selection input, and study implementation strategies.
• Ensure adherence to ICH-GCP guidelines, FDA regulations, and HIPAA requirements.
• Directly supervise and manage performance of Clinical Research Coordinators and Research Assistants.
• Monitor patient safety, adverse event reporting, and investigational product accountability.
• Oversee data entry accuracy, source documentation, and internal quality control processes.
• Assist in study budget development, financial monitoring, and sponsor invoicing.
• Serve as the primary operational contact for sponsors and CROs at assigned sites.
• Identify workflow inefficiencies and implement process improvements for oncology trials.

Job Requirements

• Bachelor's Degree in a relevant field is preferred.
• Minimum of six years of clinical research experience, with oncology focus preferred.
• Certification as a Clinical Research Coordinator (CCRC) or equivalent is desired.
• Strong knowledge of regulatory requirements, including ICH-GCP and FDA guidelines.
• Proficiency in clinical research software and data management systems.
• Excellent organizational, interpersonal, and communication skills.
• Ability to manage multiple clinical trials and teams across satellite clinics.
• Experience in budget oversight and financial performance monitoring.
• Commitment to patient safety, ethical conduct, and continuous improvement.