Clin Trials Rsrch Associate MORL

Position Summary:

The Department of Otolaryngology at the University of Iowa is seeking a Clinical Trial & Data Management Research Associate 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. The Clinical Trial & Data Management Research Associate will also perform research/clinical activities protocol development and study responsibilities regulatory guidelines and documents data collection and monitoring human resources/leadership and financial responsibilities.

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

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.

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:

• May provide functional and/or administrative supervision. Mentor new staff under direction.

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