Clinical Trials Research Specialist - Otolaryngology

SUMMARY

The Cochlear Implant Electrophysiology Laboratory in the Department of Otolaryngology – Carver College of Medicine seeks to hire a Research Audiologist/Project Coordinator to join a dynamic, interdisciplinary team of clinician researchers. Our research aims to expand the diagnostic test battery of auditory function for human cochlear implant candidates and recipients. We use electrophysiological tools to characterize the peripheral auditory system and investigate the association with surgical and performance-based outcomes. In addition to our own institutionally driven research, we frequently support manufacturer trials.

The Research Audiologist will translate clinical skills to research protocols. The individual will work as part of a team with researchers and clinicians from otolaryngology, neurobiology, genetics and communication science and will collaborate with colleagues at external institutions. Responsibilities will include knowledge of and adherence to regulatory guidelines, identification of eligible participants, recruitment/consent, coordination with scheduling, independent audiologic/research assessments (including but not limited to immittance, pure-tone audiometry, speech perception, electrical impedance, electrically evoked compound action potential, electrocochleography, stapedial reflex testing), data management and analysis, detailed documentation and record keeping, and equipment maintenance and troubleshooting. The individual should be comfortable in both surgical and non-surgical settings for intra-operative and post-operative assessments. In addition, the individual will help interpret data from a clinical perspective and will have opportunities to assist in the dissemination of research findings (e.g. development of newsletters, infographics, social media posts, oral presentations, and preparation of manuscripts), and to participate in other activities as required. 

BASIC POSITION DESCRIPTION

Apply clinical audiological skills to evaluate and execute research protocols under the leadership of the director of research. Performs a wide range of routine and advanced audiological tests, as necessary, to determine hearing status. Provide support for researchers by addressing project administrative, management and maintenance tasks related to the setting of a hearing research laboratory. Other duties may be required and assigned at times as determined by a supervisor in order to meet the needs of the organization.

KEY AREAS OF RESPONSIBILITY

Research/Clinical Activities; Subject Recruitment and Enrollment:

• Perform clinical/health care research activities and functions as a specialist/technical expert in Audiology.
• Coordinate the care of research participants according to protocols requiring a high level of judgment and independent action.
• Review new protocols and assign protocols to staff.

Protocol Development/Management of Study Responsibilities:

• Develop, edit, coordinate, manage and maintain protocols.
• Establish study-related metrics for efficiency and success.
• Prepare, evaluate and analyze reports.
• Review aggregate data from query resolutions and monitor visit reports for all studies.
• Responsible for site management and daily activities associated with clinical trials.
• Provide training and guidance; organize and facilitate meetings.
• Communicate to health care practitioners, agencies and sponsors.
• Ensure human subjects protection.
• Provide care that is safe, effective and efficient.

Data Collection and Monitoring:

• Evaluate and analyze data collection procedures and data.
• Update and maintain the requirements and specifications for the electronic data capture systems.

Regulatory Guidelines and Documents:

• Manage safety of subjects/patients.
• Assume responsibility for reportable events reporting, and any corrective actions taken.
• Manage and organize regulatory documentation.
• Prepare regulatory submissions.
• Perform on-site audits of research and clinical data.
• Communicate with IRB staff and investigators.

Human Resources/Leadership:

• May hire, develop and manage the performance of staff; assure staff is complaint with UI policies and procedures.
• May develop, implement and expand education and training activities.

Financial Responsibility:

• Perform administrative tasks to assure completion within specific timelines and budgets.
• Develop and administer budget for studies.

Facilities and Equipment Management:

• Assist in the management and maintenance of lab equipment including software updates and calibration.
• Troubleshoot issues and navigate repairs.
• Create and maintain logs of laboratory owned and manufacturer loaned equipment.
• Set up and operate research materials and equipment.
• Assist with the procurement of supplies and materials.

SUPERVISION RECEIVED

Supervision will be provided from the study investigator, Dr. Rachel Scheperle (Department of Otolaryngology), with oversite from Dr. Marlan Hansen (Department of Otolaryngology).

SUPERVISION EXERCISED

May supervise and/or facilitate the progress of trainees working on research projects.