HC/Clinical Research Associate - MORL

Position Summary:

The Department of Otolaryngology at the University of Iowa is seeking a Clinical/Healthcare Research Associate (Research Nurse) to join the Molecular Otolaryngology and Renal Research Laboratories (MORL) to coordinate a longitudinal study focusing on the complement mediated renal diseases investigated in the MORL. This position requires strong clinical skills and specialized licensing to screen patients for study eligibility and consent for the longitudinal study. The Clinical/Healthcare Research Associate will educate patients on scope of the longitudinal study, study requirements, collect data and monitor the study. The Clinical/Healthcare Research Associate will also perform research/clinical activities, protocol development and study responsibilities, regulatory guidelines and documents, and human resources/leadership.

Job Duties:

Research/Clinical Activities:

• Responsibilities include overall coordination and administration of longitudinal study.

• Perform clinical/health care research activities.

• Prepare and participate in monitoring visits; may perform activities such as patient assessments and review of medical history.

• Assists with clinical and data coordination for clinical research activities, obtain informed consent, sets up supplies for study visits, and schedules study-related procedures.

• Assure compliance with study protocol.

• Obtain and process clinical research specimens.

• Participate in national and international meetings by presenting posters and talks related to longitudinal study.

Protocol Development and Study Responsibilities:

• Consults with principal investigator and assists in development of data management plans.
• Designs forms to facilitate the collection and tracking of study participant data, biological specimens, and study procedures.
• Assist in protocol development and provide input into descriptions of routine research procedures.
• Performs critical analysis of literature relevant to the study.
• Resolve queries.
• Develop study materials.
• Triages telephone calls from patients and families.
• Serves as liaison to health care practitioners.

Data Collection and Monitoring:

• Follows study participants; manages collection of data including maintaining records of patient visits/interviews.
• Collect and enter clinical research data required in a timely manner.
• Performs data processing tasks; enters and verifies data, identifies problem data, generates queries, etc.
• Assist with determining validity of data obtained.
• Maintains study data and records.
• Revises and implementations of change in data collection.
• Conducts audits to assess quality assurance.

Regulatory Guidelines and Documents:

• Collect and maintain regulatory documents from subjects and assist in preparation of required regulatory forms and documentation according to protocol.

• Monitor compliance, gather and maintain data for any sponsored research trials, in-house trials and cooperative group studies; creates worksheets, treatment flow sheets and assorted tools to provide source documentation of protocol procedures.

• Report any reportable events to appropriate party.

Human Resources/Leadership:

• Adhere to institutional policies and guidelines.

• Adhere to MORL policies and guidelines.

• May provide functional and/or administrative supervision.

• May mentor new staff under the direction of the Principal Investigator.

• Provide direction, assignments, feedback, coaching and counseling to ensure outcomes are achieved.

Financial Responsibility:

• Assist in budget development and management of resources/supplies for study.

• Contribute to identification of increased cost/inefficient spending and cost containment measures.

• Monitors compliance of regulatory guidelines and proper maintenance of documents

• May develop, negotiate and manage budget for studies