Job Abstract

What You Will Do

• The Institutional Review Board Supervisor is responsible for guiding IRB Administration Office staff performance, including training and daily oversight of routine activities to ensure core goals are met and work is consistent, efficient, and accurate. (25%)
• Maintains a current understanding of Federal, State and local laws, regulations and guidelines governing human subject research (10%)
• In conjunction with the HRPP manager, develop and monitor policies, procedures, instructions, guidance, forms and templates for the IRB process. (10%)
• Responsible for Quality Assurance activities.
• Serve as key liaison between, and resource for, the UH IRB, IRB Specialists, Principal Investigators (PIs), clinical study sites, individual study teams and external organizations and IRBs. (15%)

Additional Responsibilities

• Performs other duties as assigned.
• Complies with all policies and standards.
• For specific duties and responsibilities, refer to documentation provided by the department during orientation.
• Must abide by all requirements to safely and securely maintain Protected Health Information (PHI) for our patients. Annual training, the UH Code of Conduct and UH policies and procedures are in place to address appropriate use of PHI in the workplace.

Education

• Master's Degree or equivalent) in health sciences, bioethics or a related degree (Required)

Work Experience

• 3 years of direct IRB administration experience (Required) and
• 3 years combined of IRB and other research related roles could be used to substitute (Required)
• Requires a background in research, with specific knowledge of research regulations and local policies.
• 2 years of direct IRB experience
• Supervisor experience (Preferred)

Knowledge, Skills, & Abilities

• Must have excellent organization skills with attention to detail. (Required proficiency)
• Accurate typing skills. (Required proficiency)
• Ability to articulate information in grammatically correct written form. (Required proficiency)
• Works independently and meets deadlines. (Required proficiency)
• Good attendance record. (Required proficiency)
• Service-oriented, self-motivated, professional, discrete, and act with integrity. (Required proficiency)
• Detail-oriented person with the ability to work independently on multiple tasks and manage time effectively. (Required proficiency)
• Strong leadership skills to train and supervise direct reports with effective experience in resource planning. (Required proficiency)
• Ability to work consistently and effectively as part of a high performance work team. (Required proficiency)
• Good judgment, initiative and problem solving skills. (Required proficiency)
• Excellent written communication skills and interpersonal and verbal communication skills. (Required proficiency)
• Ability to follow through and consistently demonstrate primary job responsibilities are current. (Required proficiency)
• Proficient in necessary computer applications. (Required proficiency)
• Basic understanding of medical terminology and knowledge of research regulations, both internal and external as well as an understanding of current NIH, DHHS, OHRP, and FDA guidelines governing human subjects research. (Required proficiency)

Physical Demands

• Standing Occasionally
• Walking Occasionally
• Sitting Constantly
• Lifting Rarely 20 lbs
• Carrying Rarely 20 lbs
• Pushing Rarely 20 lbs
• Pulling Rarely 20 lbs
• Climbing Rarely 20 lbs
• Balancing Rarely
• Stooping Rarely
• Kneeling Rarely
• Crouching Rarely
• Crawling Rarely
• Reaching Rarely
• Handling Occasionally
• Grasping Occasionally
• Feeling Rarely
• Talking Constantly
• Hearing Constantly
• Repetitive Motions Frequently
• Eye/Hand/Foot Coordination Frequently

Travel Requirements

• 10%