Clinical Research Coordinator

Clinical Research Coordinator

A leading university is seeking a Clinical Research Coordinator to support the coordination and execution of oncology clinical research studies from start-up through closeout. This role serves as a primary liaison for study participants, sponsors, and regulatory agencies while ensuring protocol compliance, accurate data management, patient safety, and successful execution of Phase IIII treatment trials in a fast-paced research environment.

Clinical Research Coordinator Responsibilities:

• Coordinate oncology clinical studies from study start-up through closeout by serving as the primary contact for research participants, sponsors, and regulatory agencies, screening and consenting participants, supporting recruitment efforts, coordinating study visits, specimen collection, treatment trial activities, and monitoring study progress.
• Collect, manage, and maintain clinical research data by completing case report forms, managing research databases, developing study documentation, assembling study kits, coordinating study procedures, and ensuring accurate and complete regulatory and research records.
• Ensure compliance with research protocols, Institutional Review Board (IRB) requirements, Good Clinical Practice (GCP), and institutional policies by preparing regulatory submissions, auditing study documentation, participating in monitoring visits and regulatory audits, and maintaining essential study documentation.
• Partner closely with principal investigators, clinical staff, finance teams, and sponsors to monitor study budgets, resolve billing issues, ensure patient safety, coordinate sponsor meetings, and support the successful execution of Phase IIII oncology treatment trials.
• Maintain effective communication with internal and external stakeholders while utilizing Microsoft Office and clinical research systems to support study operations, documentation, reporting, and regulatory compliance.

Clinical Research Coordinator Qualifications:

• 1-2 years of clinical research experience, including experience coordinating onsite oncology clinical research studies and Phase IIII treatment trials.
• 2 years of related work experience with a 2-year college degree, OR
• A Bachelor's degree in a related field or an equivalent combination of related education and relevant experience.
• Experience coordinating clinical studies from start-up through closeout, including participant recruitment, informed consent, specimen collection, study documentation, and regulatory compliance.
• Knowledge of medical terminology, clinical research regulations, IRB processes, Good Clinical Practice (GCP), and regulatory documentation.
• Proficiency with Microsoft Office and experience managing research databases, case report forms, and clinical research documentation.
• Strong attention to detail with the ability to manage multiple priorities while ensuring data accuracy, protocol compliance, and patient safety.
• Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP) certification is preferred.
• Ability to drive day or night, if necessary.