Clinical Trials Research Asst/Data Management - Department of Surgery

Position Summary

The clinical trial research assistant/ data manager will be an integral member of the research team in Dr. Vikas Dudeja’s lab in the Department of Surgery and will have a strong collaborative relationship with the Institute for Clinical and Translational Science team. The clinical trial research assistant/ data manager will apply clinical skills to administer, deliver, and evaluate research protocols.

Key Areas Of Responsibilities And Specific Job Tasks

Research/Clinical Activities; Subject Recruitment and Enrollment

• Perform clinical/health care research activities.
• Screen, recruit, enroll and obtain informed consent for clinical research activities.
• Educate patient scope of study, potential risks and benefits, possible alternative, and study requirements for patient.
• Relay information to principal investigator and verify patient eligibility.
• Oversee the recruitment of subjects and scheduling of trial-related procedures.
• Prepare study recruitment materials.

Protocol Development/Management and Study Responsibilities

• Assist in the design, development, execution, administration and maintenance of protocols and clinical studies and provide input into descriptions of complex research procedures.
• Assist patents with problems related to protocol.
• Oversee CRF development.
• Review query reports. Resolve all monitoring visit issues.
• Perform and monitor randomizations.
• Develop complex study materials.
• Serve as liaison to local health care practitioners, agencies, and sponsors.

Data Collection and Monitoring

• Participate in the design; development and testing of clinical research trial data systems.
• Acts as a liaison between health care information systems and research data systems.
• Validate data and make recommendations for resolution.

Regulatory Guidelines and Documents

• Manage and organize regulatory documentation.
• Prepare regulatory submissions.
• Preform on-site audits of research and clinical data.
• Monitor compliance of regulatory guidelines and proper maintenance of documents.
• Prepare and present Institutional Review Boards or other submissions and required regulatory documents.
• Assist with IRB, ACURF or similar protocol submissions.

Financial Responsibility

• Participate in preparation of grant applications for extramural funding.
• Provide assistance with tracking and reconciling grant/trial budget free balances and identify opportunities to ensure that grant funding is being used as intended and awarded.

Type of Position: Specified Term. Initial appointment is for one year. Appointment may be extended based on performance and availability of funding.

Percent of Time: 100%, 40 hours per week

Schedule: 40 hour week with a 30 minute lunch

Location: University of Iowa Health Care Medical Center on the University Campus

Pay Grade: 3A

Benefit Highlights

• Regular salaried position located in Iowa City, Iowa
• Fringe benefit package including paid vacation; sick leave; health, dental, life and disability insurance options; and generous employer contributions into retirement plans. For more information on benefits, please visit: https://hr.uiowa.edu/benefits/employee-benefits

Education

• A Bachelor’s degree in a Health Science field or an equivalent combination of education and research experience is required.

Experience Requirements

• Excellent written and verbal communication skills are required.
• Ability to work nights and weekends is required.
• Proficiency in Microsoft Word, Outlook and Excel is required.

Desired Qualifications

• Basic clinical research experience is desirable.
• Working knowledge of Good Clinical Practice (GCP) is desirable.
• Previous experience writing manuscripts for publication is desirable.
• Experience with REDCap, Epic, I-CART, and ACCESS is desirable.
• Previous experience in data collection and entry is desirable.
• Experience in processing research regulatory documents is desirable.
• A current license to practice nursing in Iowa by the time of hire is desirable.
• The ability to work independently is desirable.
• Excellent time management skills and ability to perform detail-oriented work is desirable.

Application Process: 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 references will be requested at a later step in the recruitment process. This position is not eligible for University sponsorship for employment authorization.

For additional questions, please contact devin-deanda@uiowa.edu

Additional Information

• Classification Title: Clin Trials Rsrch Asst/Data Mg
• Appointment Type: Professional and Scientific
• Schedule: Full-time
• Work Modality Options: On Campus

Compensation

• Pay Level: 3A

Contact Information

• Organization: Healthcare
• Contact Name: Devin DeAnda
• Contact Email: devin-deanda@uiowa.edu