Sr Human Subject Research Specialist

Responsibilities

• Manages and oversees the activities that establish, monitor and maintain human subject research.
• Plans, directs, monitors and coordinates all phases of human subject research, which may include multi-site, community-based research or multiple therapeutic areas.
• Manages, designs, implements and evaluates study changes.
• Serves as study manager at senior professional level for the Principal Investigator, Dr. Robert Block’s Preventive Cardiology Research program.
• Provides professional direction and coordination within the project and maintains a working knowledge of the area(s) of expertise by reviewing research literature, abstracts, attending pertinent meetings and seminars.
• Communicates and coordinates with Dr. Block to ensure each subject’s safe and proper completion of the study protocol, including weekly meetings with PI.
• Trains other staff about activities associated with conducting human subject research specific to study protocols and generally in compliance with Good Clinical Practice (GCPs) guidelines.
• Designs, develops, implements, monitors and manages systems and methods to ensure quality, safety, efficiency and consistency in the processing of data.
• Maintains regular contact with Principal Investigator and other members of the research team, the eRecord electronic health record team, and the RSRB to ensure implementation of project deliverables within timelines, and to assess gaps/needs.
• Serves as the primary communicator for project reporting and compliance, with sponsors and the University of Rochester’s intramural systems.
• Develops, documents and implements Standard Operating Procedures (SOPs) at all sites and ensures adherence to established SOPs.
• Keeps current with all federal, state, sponsor and institutional policies and laws, SOPs and guidelines.
• Demonstrates accountability for continuous learning in accordance with GCPs.
• Keeps current with industry standards, best practices and trends in therapeutic areas relevant to research studies.

Requirements

• Bachelor’s degree required
• 5 years of experience in human subject research coordination required
• or equivalent combination of education and experience required
• Experience as Human Subject Research Specialist II preferred

Qualifications

• Knowledge, Skills And Abilities:
• Word processing and data analysis software required

Skills

• Excellent communication skills required
• Solid computer skills with knowledge of word processing, database utilities, internet navigation, and email programs required

Benefits

Not specified

Pay

$60,431.00 - $84,603.00

Schedule

Part time