HC/Clinical Research Associate - MORL

UIOWA•Iowa City, IA

About The Position

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

Requirements

A BSN or an equivalent combination of education and experience is required
A minimum of 1-year clinical experience in a nephrology-related position
A current, valid Iowa Registered Nurse license
Excellent written and verbal communication skills
Phlebotomy 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

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

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
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
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
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
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