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
Required Qualifications:
- 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)
Desired Qualifications:
- 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.
Position and Application Details
In order to be considered for an interview, applicants must upload the following documents and mark them as a “Relevant File” to the submission:
- Resume
- Cover Letter
Job openings are posted for a minimum of 7 calendar days and may be removed from posting and filled any time after the original posting period has ended.
Successful candidates will be required to self-disclose any conviction history and will be subject to a criminal background check and credential/education verification. Up to 5 professional references will be requested at a later step in the recruitment process.
For additional questions, please contact ashley-rayer@uiowa.edu.
Equal opportunity employer
The University of Iowa is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment free from discrimination on the basis of race, creed, color, religion, national origin, age, sex, pregnancy (including childbirth and related conditions), disability, genetic information, status as a U.S. veteran, service in the U.S. military, sexual orientation, or associational preferences.
Persons with disabilities who need assistance or accommodations with the application or interview process may contact University Human Resources/Faculty and Staff Disability Services, (319) 335-2660 or fsds@uiowa.edu. For jobs in UI Health care, please contact UI Health care Leave & Disability Administration at 319-356-7543.
