Clinical Research Coordinator II - Pediatric Clinical Research Unit

About This Role

This position within the Pediatrics Clinical Research Unit (PCRU) assists investigators as a coordinator of complex clinical research studies. The role is responsible for multiple research studies simultaneously, acting as a liaison with the school, sponsoring agency, community, and study participants. It involves managing and recording all phases of study protocol as required by the sponsoring agency to ensure compliance, and coordinating with multidisciplinary teams to maintain continuity of care while safeguarding human subjects and promoting research integrity.

Responsibilities

• Confer with the PI to assist in developing plans for research projects and discuss the interpretation of results
• Collaborate in the preparation of manuscripts for publications and preparation of grant proposals to sponsoring agencies
• Assist in the preparation of amendments to protocols and/or modifications to study design as appropriate
• Coordinate the development of forms, questionnaires, and the application of research techniques
• Assist in writing instructional procedure manuals for study progress, data collection, and coding
• Review journals, abstracts, and scientific literature to keep abreast of new developments and to obtain information regarding previous studies to aid in the planning of new studies
• Routinely implement and manage all phases of study/protocol, including recruitment, enrollment, eligibility, and informed consent
• Ensure compliance with protocol guidelines and requirements of regulatory agencies
• Establish record-keeping systems
• Make assessments and determinations of participants’ progress in the study
• Analyze, investigate, and report adverse events
• Make decisions on when to notify physicians of issues, when to stop participant inclusion, and/or to make and/or recommend adjustment of the protocol of particular participants
• Resolve IRB/protocol management issues and recommend corrective action as appropriate
• Serve as liaison with funding or sponsoring agency
• Evaluate and interpret collected clinical data in conjunction with PI as appropriate
• Prepare oral or written presentations or reports and analyses setting forth progress trends and provide recommendations or conclusions
• Perform other duties incidental to the work described herein

Requirements

• Bachelor’s degree or combination of education and/or experience may substitute for minimum education
• Clinical Research (2 Years) experience

Nice to have:

• Clinical Research skills
• Clinical Study Protocols skills
• Database Management skills
• Research Projects skills