Clinical Trials Research Asst/Data Management - Department of Surgery

University of Iowa•Iowa City, IA

10h•Onsite

About The Position

The clinical trial research assistant/data manager will be an integral member of Dr. Vikas Dudeja’s lab in the Department of Surgery and will collaborate closely with the Institute for Clinical and Translational Science team. The role applies clinical skills to administer, deliver, and evaluate research protocols. The position is a specified-term appointment, initially for one year, with possible extension based on performance and funding availability. It is a 100% appointment, 40 hours per week, located at the University of Iowa Health Care Medical Center on the University campus in Iowa City, Iowa. The schedule includes a 30-minute lunch.

Requirements

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.

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.
A current Iowa license to practice nursing 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 research participants, and obtain informed consent.
Educate patients about study scope, potential risks and benefits, alternatives, and requirements.
Relay information to the principal investigator and verify patient eligibility.
Oversee participant recruitment and schedule trial-related procedures.
Prepare study recruitment materials.
Assist with the design, development, execution, administration, and maintenance of protocols and clinical studies, and contribute descriptions of complex research procedures.
Assist patients with problems related to protocols.
Oversee case report form (CRF) development, review query reports, resolve monitoring visit issues, and perform and monitor randomizations.
Develop complex study materials and 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, prepare regulatory submissions, and monitor compliance with regulatory guidelines and document-maintenance requirements.
Perform on-site audits of research and clinical data.
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 and trial budget balances and identify opportunities to ensure funding is used as intended and awarded.