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JOB DESCRIPTION AND POSITION REQUIREMENTS:

The Penn State College of Medicine, Department of Pediatrics, in Hershey, PA, is seeking a Clinical Research Coordinator. This position provides operational oversight for research projects and activities within a department including oversight of project timelines and deliverables; coordination of workflows between research teams, external organizations, and stakeholders; budget management; facilitation of data collection and management plans; preparation and submission of grants, proposals, and compliance documents; records management and documentation of studies; and ensures program compliance with government regulations, university policies, and institutional review board requirements.

• Develop operating procedures and workflow processes to ensure that the scope and direction of the project is on schedule; monitor project progress and deliverables; generate reports and deliver presentations to stakeholders
• Coordinate meetings, trainings, and presentations between participants, research teams, sponsors, and internal or external organizations; create agendas for meetings and conduct training sessions
• Develop recruitment and data collection plans including methods, tools, goals, and evaluation procedures
• Coordinate and create documentation for projects including operating procedures, data collection forms, templates, clinical trial submissions, and manuals
• Author, review, and submit regulatory compliance documents and maintain communications with internal and external entities (IRB, ORA, NIH, Clinical Trials Office and HRPP), maintain relationships with governmental or regulatory agencies, research organizations, and central University offices
• Direct the process for reviewing and approving new clinical trials
• Identify, communicate, and resolve project issues; recommend and implement solutions
• Manage and track budgets and resources to assure efforts align with project/study guidelines; process financial transactions in support of the project including travel, p-card, transfers, and budget realignments
• Track and document personnel and project certifications, training completion, and compliance records
• Coordinate award administrative tasks; assist researchers with proposal preparation and submissions
• May supervise staff members, including hiring, development, and performance management

This position will be filled at an Professional or Inte