Clin Trials Rsrch Associate - MORL

University of Iowa•Iowa City, IA

6h•Onsite

About The Position

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.

Requirements

A Bachelor's degree or an equivalent combination of education and experience is required.
A minimum of 1-year research experience in a nephrology-related position.
Excellent written and verbal communication skills.
Experience with Epic
Experience with comprehensive evaluation of patient clinical history and data collection
Experience with scheduling procedures and visits
Ability to manage complex information with attention to detail and a high level of accuracy
Excellent organizational skills
Proficiency in computer software applications (MS Word, Excel, Outlook and PowerPoint)

Nice To Haves

Phlebotomy skills
Prior research experience.
Familiarity with databases such as Redcap or Microsoft Access is highly desired
Knowledge of IRB guidelines and procedures
Knowledge of University of Iowa Healthcare policies, procedures, regulations and guidelines is desired.

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