Clinical Trials Research Asst/Data Management - Department of Surgery

UIOWA•Iowa City, IA

3d•Onsite

About The Position

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 work collaboratively with the Institute for Clinical and Translational Science team. The role applies clinical skills to administer, deliver, and evaluate research protocols. The position conducts clinical and health care research activities, including screening, recruiting, enrolling, and obtaining informed consent from participants. It supports the development and administration of protocols and clinical studies, manages study materials and data systems, and helps ensure that research activities comply with regulatory guidelines. The role also contributes to grant applications and tracking trial and grant budgets. This is a specified-term, regular salaried position with an initial one-year appointment that may be extended based on performance and funding availability. It is 100% time, or 40 hours per week, with a 30-minute lunch. The position is located at the University of Iowa Health Care Medical Center on the University campus in Iowa City, Iowa.

Requirements

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.

Nice To Haves

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 processing research regulatory documents.
Current license to practice nursing in Iowa by the time of hire.
Ability to work independently.
Excellent time management skills and ability to perform detail-oriented work.

Responsibilities

Perform clinical and health care research activities.
Screen, recruit, and enroll participants, and obtain informed consent for clinical research.
Educate patients about study scope, potential risks and benefits, alternatives, and study requirements.
Relay information to the principal investigator and verify participant eligibility.
Oversee subject recruitment and schedule trial-related procedures.
Prepare study recruitment materials.
Assist with the design, development, execution, administration, and maintenance of protocols and clinical studies, including contributing descriptions of complex research procedures.
Assist patients with problems related to protocols.
Oversee case report form (CRF) development and review query reports.
Resolve monitoring visit issues and perform and monitor randomizations.
Develop complex study materials.
Serve as a liaison to local health care practitioners, agencies, and sponsors.
Participate in designing, developing, and testing clinical research trial data systems.
Act as a liaison between health care information systems and research data systems.
Validate data and recommend resolutions.
Manage and organize regulatory documentation and prepare regulatory submissions.
Perform on-site audits of research and clinical data.
Monitor compliance with regulatory guidelines and proper document maintenance.
Prepare and present Institutional Review Board (IRB) or other submissions and required regulatory documents.
Assist with IRB, ACURF, or similar protocol submissions.
Participate in preparing grant applications for extramural funding.
Assist with tracking and reconciling grant/trial budget balances and identify opportunities to ensure grant funding is used as intended and awarded.