Clinical/HC Research Specialist - Otolaryngology

Research/Clinical Activities

Perform clinical/health care research activities and functions as a specialist/technical expert in Audiology.

Care for 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 compliant 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.

Aid in the procurement of supplies and materials.