Clinical Research Regulatory Specialist - RNEL presso University of Pittsburgh

Department of Physical Medicine and Rehabilitation's Rehab Neural Engineering Labs (RNEL) is a set of labs committed to improving the quality of life of individuals with neurological impairments by advancing the scientific understanding of motor and somatosensory systems to engineer new rehabilitation therapies and technologies. (See https://www.rnel.pitt.edu/). RNEL is a world leader in clinical neural interface research, having made headlines in recent years for work in brain-computer interfaces, spinal cord stimulation, and deep brain stimulation to improve movement and provide sensation in impaired or missing limbs. RNEL is a highly collaborative environment that strives to provide an exciting, challenging, and supportive environment where all individuals can thrive.
The job candidate will help establish and coordinate clinical device trials and serve as a regulatory expert for all labs of the Rehab Neural Engineering Labs. We expect that the Clinical Research Regulatory Specialist will be familiar with conducted device-related regulatory trials and will provide expert guidance related to FDA and IRB regulations, study documentation, data and safety monitoring board administration, and reporting requirements. Device trials are often conducted as part of an FDA Investigational Device Exception, though some non-significant risk studies are conducted with only IRB approval.  Trials may be single or multi-site and could be investigator or industry sponsored. 
The Clinical Research Regulatory Specialist will communicate with the research team, clinicians, and participants to ensure strict adherence to the research protocol and ensure compliance with all regulations, policies and procedures. They will establish documentation that provides a clear and complete history of research activities and events.
The candidate will be responsible for working with study team members to complete IDE and IRB submissions (study startup, modifications, continuing reviews, required reporting) and maintaining the regulatory documents in an organized fashion. The candidate will advise on and coordinate regular monitoring procedures both internally and externally, such as oversight by a data and safety monitoring board, funding agency, or industry-sponsor. The candidate may have primary responsibility for specific device trials and collaborations with others at RNEL to assure proper understanding of FDA and IRB requirements.
 

Ensures that all federal regulations are adhered to and maintains up-to-date information regarding federal regulations and ethical considerations. Provides regulatory protocol training. Crafts and distributes applicable regulatory documents for research communities. Submits protocol reviews, verifies required documents, and handles complex issues.

• The preparation, coordination, implementation, and evaluation/monitoring of study progress including
  o    Setting up study infrastructure, protocols, and processes
  o    Establishing and updating Investigational Device Exemptions (IDEs)
  o    Draft and otherwise assist with IRB submissions, renewals, and modifications
  o    Leading communication with data and safety monitoring boards and study sponsors
  o    Screening medical records and registries for study eligibility
  o    Recruiting and consenting participants 
  o    Collecting, monitoring, cleaning and otherwise managing data (e.g., creating data collection forms via REDCap and abstracting medical record data)
  o    Administering questionnaires
  o    Reimbursing subjects through Vincent
  o    Maintaining research databases and study records
  o    Monitoring data and correcting for any collection errors
• Developing/maintaining proficient understanding of FDA regulations and requirements for IDE’s and device research 
• Maintaining regulatory compliance
• Communicating with various research entities (study team members, PIs, Data & Safety Monitoring Boards, funding oversight, and regulatory compliance)
• Serving as regulatory expert for RNEL labs, especially about FDA requirements
• Coordinating protocol related research procedures and study visits
   

Must be able to sit or stand for long periods of time. Able to use computer, telephone, copier, fax, and other essential office equipment. Able to travel to clinical locations for meetings with study participants. Carry study files and equipment to data collection locations.