Clinical Research Coordinator; SOM Pediatric Endocrinology

Johns Hopkins, founded in 1876, is America's first research university and home to nine world-class academic divisions working together as one university.

Researchers at Johns Hopkins University conduct clinical trialsand clinical studies to discover new ways to prevent and treat diseases and other health problems. The School of Medicine,Pediatric Endocrinology is seeking a Clinical Research Coordinator who will administratively coordinate clinical protocol implementation, typically for a single study to ensure the efficient logistical implementation of the study activities and provide administrative support for research-related regulatory issues.

The Clinical Research Coordinator will help manage theday-to-day administration of research programs focusing on obesity,insulin resistance, and type 2 diabetes in children, as well as the cardiovascular complications associated with these conditions. Studies are patient-oriented, clinical, and involve human subjects.

• Coordinate all activities of a clinical research study toensure adherence to protocol and validity of findings.
• Participate in clinical study start-up meeting.
• Assist research nurses, study coordinators, principal investigators, and other study personnel in executing protocol-related activities.
• Explain the study background and rationale for the research to potential and current participants
• Contribute to the development of recruitment strategy for participants for assigned study.
• Implement a variety of techniques for recruitment as appropriate, e.g., print and web-based advertisements, contact referring physicians, participate in community events, etc.
• Independently conduct the consenting process or ensure consentis obtained on appropriate participants.
• Schedule participants for required activities and provide any special instructions prior to upcoming tests/exams.
• Serve as liaison to study participants.
• Assist with setup of the data collection system and enter and organize data.
• Assist in coordinating study meetings.
• Participate in study meetings and provide updates on protocol implementation status and make recommendations on operational issues.
• Assist with the preparation of submissions to the Institutional Review Board (IRB)
• Liaison with IRB on administrative matters and facilitate communications with the PI.
• Conduct literature searches to provide background information.
• Obtain and maintain excellent operating knowledge of assigned clinical protocol, clinical equipment, and clinical computer systems.
• Develop moderately complex tracking database/spreadsheet basedon study requirements utilizing Excel, REDCap, or similar software applications.
• Assists with data analysis, interpretation, manuscript and abstract preparation.
• Oversee budget expenditures for study operations.
• Other duties as assigned.

• Bachelor's Degree in a related field.
• Additional education may substitute for required experience and additional related experience may substitute for required education beyond a high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula.

• Related undergraduate or work experience in human subjects research.
• Familiar with complex tracking databases, Excel, REDCap, orsimilar software applications.
• Spanish language fluency would be helpful.
• Familiarity with data analysis software is a plus.

• Attention to Detail
  - Awareness
• Clinical Trial Management System
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• Data Entry
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• Data Collection and Reporting
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• Data Management and Analysis
  - Awareness
• Interpersonal Skills
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• Oral and Written Communications
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• Organizational Skills
  - Awareness
• Project Coordination
  - Awareness
• Regulatory Compliance
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