40 hours/week, 6 Month Assignment, Possible extension/conversion
A leading university is seeking a Clinical Research Coordinator 2 to independently manage clinical research activities and support oncology treatment studies in a healthcare setting. This role will oversee study operations from participant recruitment through regulatory compliance, data management, and sponsor coordination while ensuring adherence to clinical research standards and applicable regulations.
Clinical Research Coordinator 2 Responsibilities:
Manage subject recruitment, enrollment, and retention activities, and oversee data collection systems, including organizing, monitoring, analyzing, and interpreting study data to support clinical research objectives.
Coordinate study operations by developing project schedules, leading team meetings, supervising and mentoring research staff or students, and supporting study budgets, milestone tracking, and sponsor invoicing activities.
Ensure regulatory compliance through oversight of Institutional Review Board submissions and renewals, FDA and Investigational New Drug application activities when applicable, study documentation reviews, audits, and implementation of corrective actions to maintain Good Clinical Practice standards.
Collaborate with principal investigators, sponsors, and research teams to monitor serious adverse events, resolve study queries, support protocol execution, and recommend process improvements and best practices.
Monitor study conduct and operational activities to ensure compliance with research protocols, HIPAA requirements, FDA regulations, and institutional policies while supporting continuous process improvements.
Clinical Research Coordinator 2 Qualifications:
2+ years of clinical research experience or an equivalent combination of education and relevant experience.
Experience using EPIC electronic medical record systems.
Experience working onsite within a healthcare institution; CRO or pharmaceutical CRA-only backgrounds are not preferred.
Knowledge of research protocols and regulatory requirements, including HIPAA, FDA regulations, Institutional Review Board requirements, and Good Clinical Practice guidelines.
Knowledge of medical terminology.
Proficiency with Microsoft Office applications and database systems.
