The Institute for Clinical and Translational Science (ICTS) is seeking a Clinical Trial Research Assistant/Data Manager to join the ICTS Coordinator Core as an integral member of our research team. This position provides essential research support by performing activities critical to advancing the ICTS research mission, strengthening research infrastructure, and fostering innovation through collaborative research support. The successful candidate will apply clinical and research skills to administer, coordinate, deliver, and evaluate clinical research protocols while supporting investigators and study teams across a portfolio of clinical trials.

Duties to include but not limited to:

Research/ Clinical Activities; Subject Recruitment and Enrollment

·Perform clinical/health care research activities in various departments

·Screen, recruit, enroll and obtain informed consent for clinical research activities

·Educate patient on scope of study, potential risks and benefits, possible alternatives, and study requirements for patient.

·Relay information to principal investigator and verify patient eligibility.

·Administer study treatments and report adverse reactions.

·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 patients with problems related to protocol.

·Oversee CRF development and database development and maintenance.

·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 clinical 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.

·Perform 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.

For a full job description, please send an e-mail to the contact listed below.

Percent of Time: 100%

Pay Grade: 3A

https://hr.uiowa.edu/pay/guide-pay-plans

Benefits Highlights:

-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 about Why Iowa?, click here

Required Qualifications

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

·Excellent written and verbal communication skills.

·Ability to work nights and weekends.

·Proficiency in Microsoft Word, Outlook and Excel.

Desirable Qualifications

·Basic clinical research experience.

·Working knowledge of Good Clinical Practice (GCP)

·Previous experience writing manuscripts for publication

·Experience with REDCap, Epic, I-CART, and ACCESS

·Previous experience in data collection and entry

·Experience in processing research regulatory documents

·A current license to practice nursing in Iowa by the time of hire

·The ability to work independently

·Excellent time management skills and ability to perform detail-oriented work

Position and Application Details

Applicants must upload a Resume and Cover Letter and mark them as a 'Relevant File' in order to be considered.

Job openings are posted for a minimum of 7 calendar days and may be removed after the 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 verification. Up to 5 professional references will be requested later in the recruitment process.

For additional questions, please contact amy-stewart@uiowa.edu

About ICTS: The Institute for Clinical and Translational Science (ICTS) at the University of Iowa was approved by the Iowa Board of Regents in 2007 to support the work of investigators involved in clinical and translational science. Our mission is to accelerate translational science through programs to develop the translational workforce, to promote engagement of community members and other stakeholders, to promote research integration across the lifespan, and to catalyze innovative clinical and translational research. These efforts will lead to the development of novel therapies and healthcare delivery strategies, the integration of translational research and clinical practice, and, ultimately to measurable improvements in the health of Iowa and the nation.