"Clinical Research Coordinator"

Position Summary

Under direction of Clinical Nephrology Faculty, this individual will independently carry out studies of children with kidney disease. Responsible for screening patients for trial participation, enrolling patients, monitoring protocol implementation, completing required forms, reporting results and regulatory submission. Creates study-specific data collection and statistical and analytical reports. Responsible for managing and coordinating clinical studies as members of the team and will work closely with multidisciplinary teams and participate in subject research activities throughout the studies. May assist in writing articles and summarizing papers for submission.

Key Responsibilities

• Responsible for daily operations of the study. Implements processes and procedures to meet study goals and protocol requirements. May participate in training Clinical Research Assistants and prepare study related training materials as needed in collaboration with the Principal Investigator and/or designee.
• Consents and enrolls patients for studies by providing detailed information on the clinical study to prospective participants and families. Is responsible for understanding and adhering to all policies and procedures and responds to all inquiries. Evaluates the suitability of study candidates and makes selections based on clinical knowledge of each study. Provides input for updates of SOPs and drafting of new quality documentation.
• Coordinates and prepares with minimal supervision the necessary documentation for Institutional Review Board (IRB) and external stakeholders on submissions and track progress to review and approval.
• Serves as liaison between local study sites and Clinical Coordinating Center regarding study procedures and operations and protocol interpretation. Ensures on site and subcontract operations are consistent with overall study requirements for database maintenance, coding, completion and computer input of study forms, deadlines and other related issues. Maintains regulatory binders and all study documentation, monitors adverse events and reporting thereof, handles protocol amendments.
• Creates tracking systems and assist with developing processes to enhance efficiency and effectiveness of study operations and data management, such as patient appointment scheduling, and completion and tracking of study data and forms.
• Create and prepare data collection statistical reports and analytical summaries for distribution to the study research team for review and analysis. May write articles and summaries of studies for submission. May present study results at local and national meetings.

Minimum Qualifications

Education:

• A Bachelor's Degree is required, Master's Degree preferred.

Experience:

• A minimum of 2 years of relevant experience is required.