Summary

Manages clinical research study operations in the Department of Pediatrics for the Research Resources Office. Manages the day to day operations for multiple studies. Leads the planning and scheduling activities for assigned clinical study assignments. Oversees study data collection and documentation activities and assignments. Manages Research Resources Office clinical research staff.

Job Duties

• Manages complex clinical research studies in Research Resources Office.
• Manages clinical research employees, their activities and workload.
• Leads the planning and scheduling activities for direct reports and provides feedback to leadership on study assignments
• Oversees daily work of direct reports and provides ongoing feedback and coaching on RRO SOPs and clinical research conduct.
• Manages a team of research coordinators and data managers. Responsible for their development, administrative actions, and performance reviews.
• Develops and presents training and education on procedures related to sample processing, storage, and shipment. - Manages the day to day operations for multiple studies.
• Under the study directives, manages overall study conduct, by ensuring subject safety is maintained, protocol activities are appropriately carried out, and regulations/GCP practices are followed.
• Ensures good clinical practice standards, institutional and federal compliance regulations are adhered to.
• Oversees reporting and compliance activities.
• Responsible for the creation of required study tools, such as Manual of Operations, source documents, and study orders to ensure seamless operations and accurate data collection
• Mentors junior staff in setting up new studies, including multi-center trials
• Leads Principal Investigators with electronic database development
• Creates and reviews SOP's for efficiency

Minimum Qualifications

• Bachelor's degree.
• Four years of relevant experience. 

Preferred Qualifications

• Certification as either a Clinical Research Professional (CRP), or Clinical Research Coordinator (CRC) from the Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP)