Human Sub Research Spec II

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ESSENTIAL FUNCTIONS

• Participant recruitment and enrollment: Oversees, coordinates and conducts human subject research activities for single or multiple sites. Recruits and enrolls participants.
• Recruitment strategies and materials: Develops, implements and evaluates recruitment strategies, materials, information and data systems, as well as study management systems.
• Participant retention: Follows up with study participants regarding assessments and document communications, including protocol deviations.
• Study design: Participates in the planning, development and implementation of study design, budgets, protocols, consent forms, processes and policies that may include multiple therapeutic areas.
• Supervisory duties: Trains research staff about activities associated with conducting human subject research specific to study protocols and generally in compliance with Good Clinical Practice (GCPs) guidelines and sponsor requirements. Directs the activities of subordinate staff and relevant others to gather, compile and analyze study information.
• Project Management: Represents sites, providers, study team, patients, study participants and the University to develop, monitor and maintain working relationships, positive communications and effective results with regard to the coordination of human subject studies. Responsible for supporting the contacts and relationships between and among Principal Investigator, research staff, study sites, sponsoring and regulatory agencies.
• Data Management: Develops, implements and monitors systems and methods to ensure quality, safety, efficiency and consistency in the processing of human subject research data. Reviews study progress, including data, finances, documentation and reporting deliverables. Designs, develops, implements, monitors and manages systems and procedures for the purpose of tracking study progression.
• Regulatory: Coordinates and monitors financial data for budget and variance reporting, and for compliance with all institutional requirements for adequate system controls. Keeps current with all federal, state, sponsor and institutional policies and laws, standard operating procedures, guidelines, and implements and monitors resulting study changes. Demonstrates accountability for continuous learning in accordance with Good Clinical Practice guidelines. Keeps current with industry standards, best practices, and trends in therapeutic areas relevant to research studies and designs, implements and monitors resulting study changes.

QUALIFICATIONS

• Bachelor’s degree required
• 3 years of experience required
• or equivalent combination of education and experience required Experience as Human Subject Research Coordinator 1 preferred
• Word processing and data analysis software required
• Professional Research Coordinator Certification (SoCRA or ACRP) preferred

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