Job Abstract

The Human Research Protection Program Specialist serves as the liaison within and amongst the IRB Administration Office, Research Compliance, UH Compliance, the CWRU Conflicts of Interest Department, the UH IRB committees, and the UH research community. The goal of the Human Research Protection Program Specialist role is to support the IRB Specialists and the Research Compliance Specialists in the IRB review and investigative and auditing process to promote research integrity and encourage the safety and welfare of research participants. The Human Research Protection Program will serve as a bridge between research compliance and the UH IRB Administration Office.

• Maintains a current understanding of Federal, State and local laws, regulations and guidelines as well as UHCMC IRB and UH research policies governing the protection of human research participants. (5%)
• Assists in high level IRB and Compliance related initiatives. Such duties might include:
  
  • Handling Conflicts of Interest issues (including reporting, tracking, and creating management plans)
  
  • Administration of the UH Data Safety and Monitoring Committee
  
  • Facilitating internal quality improvement tasks
  
  • Supporting AAHRPP accreditation activities
  
  • Tracking and evaluating internal metrics
  
  • Assisting with new staff training and development
  
  • Helping to process and resolve Reportable New Information submission
  
  • Notify and monitor PIs leaving the institution to ensure a smooth transition
  
  • Identifying appropriate internal continuing education opportunities (40%)
  
  
• Supports the investigative and auditing process for Research Compliance by providing auditing support for larger studies, scribing services for compliance interviews, and reviewing reports, as well as managing emails, notifications, follow ups, and general communication. (30%)
• Functions as a liaison within and between the IRB committees, UH Compliance, CWRU Conflicts of Interest Department, Research Compliance, the IRB
  Administration Office and the Research Community. (5%)
• Provide expert submission/research related consultation, direction, and guidance for other IRB or Compliance specialists, investigators, or study personnel. (10%)
• Participates in special projects / assignments that relate to quality improvement, process improvement, and training. (10%)

• 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

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

Work Experience

• An overall understanding of research stemming from experience in IRB administration, research administration, regulatory affairs clinical and/or laboratory research. (Required) and
• Research monitoring or auditing experience. (Preferred) and
• 3 years of direct experience working in IRB administration or Research Compliance can substitute for the research certification at manager’s discretion. (Required)

Knowledge, Skills, & Abilities

• Knowledge of research regulations, both internal and external. (Required proficiency)
• Understanding of current NIH, DHHS, OHRP, and FDA guidelines governing human subjects’ research. (Required proficiency)
• Thorough understanding of responsible conduct of research and misconduct regulations. (Required proficiency)
• Ability to clearly articulate information both verbally and in writing. (Required proficiency)
• Must have exceptional interpersonal and organizational skills with attention to detail. (Required proficiency)
• Works independently and meets deadlines. (Required proficiency)
• Dependable, self-motivated, professional, and act with integrity. (Required proficiency)
• Ability to perform multiple duties simultaneously and to manage occasional increased workload volumes. (Required proficiency)
• Proficient in use of PC and all MS Office software. (Required proficiency)

Licenses and Certifications

• ACRP Certified Professional (ACRP-CP) (Required) and
• Certification in Human Subjects Protection (CITI) within 30 Days (Required)
• CCRP (Required) and
• CHRC (Required)

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%