Clinical Research Coordinator Manager

Overview

• Manage and oversee clinical research operations for oncology trials at multiple satellite sites.
• Ensure compliance with regulatory guidelines, protocols, and site SOPs.
• Supervise Clinical Research Coordinators and Research Assistants, providing training and performance evaluations.
• Collaborate with sponsors, CROs, and stakeholders for effective study management.
• Implement process improvements for oncology research services and workflow efficiency.
• Maintain audit readiness and ensure high-quality data integrity.
• Support financial oversight, including budget development and expense reconciliation.
• Promote patient safety and ethical conduct in all research activities.

Key Responsibilities & Duties

• Lead protocol feasibility assessments, site selection, and study implementation strategies.
• Oversee IRB submissions, amendments, and regulatory document maintenance.
• Ensure informed consent processes comply with ethical and regulatory standards.
• Monitor enrollment metrics and implement corrective strategies as needed.
• Supervise investigational product handling, storage, and accountability.
• Collaborate with pharmacy and infusion nursing staff for protocol-required services.
• Track and reduce data queries and protocol deviations across sites.
• Support strategic planning for growth in oncology trials and infusion-based studies.

Job Requirements

• Bachelor's degree preferred; advanced knowledge of clinical research operations.
• Minimum six years of clinical research experience, with oncology focus preferred.
• Certification in Clinical Research Coordination (CCRC) or equivalent desired.
• Proficiency in clinical research software and data management systems.
• Strong organizational, interpersonal, and leadership skills.
• Knowledge of ICH-GCP guidelines, FDA regulations, and HIPAA compliance.
• Ability to oversee budget development and financial performance monitoring.
• Experience in managing multi-site clinical research operations.