Clinical Trials Research Assistant - Department of Surgery

This position involves conducting and managing sponsored and non-sponsored clinical trials and studies within the parameters of applicable study protocols for Acute Care Surgery patients. Responsibilities include screening for eligibility, recruiting, consenting, and monitoring research subjects, as well as maintaining case reports and databases. The role requires collaboration with researchers and investigators, thorough knowledge of study design and protocols, and familiarity with IRB procedures and policies. Work may involve evening, night, or weekend hours due to enrollment protocols.

Responsibilities

• Assist Acute Care Surgery faculty in the conduct of clinical trials and manage acute care and trauma surgery data within study protocols.
• Recruit and enroll participants, ensuring prerequisites are complete and conform to required parameters.
• Explain study intent to participants/family and assist in obtaining consent per study protocol.
• Schedule participants for procedures or follow-ups as required by the study protocol; maintain records of visits and interviews.
• Prepare and present educational materials for participants and staff to carry out the protocol.
• Communicate protocol deviations and concerns immediately to the Principal Investigator (PI).
• Troubleshoot and analyze protocols as skills develop; propose modifications to collaborative researchers or PI.
• Maintain study data and records; prepare monthly research progress reports and attend weekly divisional research meetings.
• Screen electronic medical records daily to recruit and enroll participants and assess eligibility for ongoing trials.
• Assist in the preparation, calibration, and maintenance of necessary equipment.
• Assist with procurement and storage of supplies and materials; may initiate purchasing requests and monitor accounts/expenditures.
• Maintain all regulatory documents for each trial following University policy; update regulatory binders as needed.
• Prepare documentation related to reportable events and provide information to IRB and sponsors.
• Present new study protocols to Acute Care Surgery faculty and staff as needed.
• Provide training to faculty and staff regarding research-related clinical activities and protocols.
• Ensure human research subject training is up-to-date for all involved faculty and staff.
• Support budget negotiations for clinical studies with sponsors and reconcile invoices to ensure study-related costs are paid.
• Reconcile payments in the University of Iowa I-CTMS subject tracking system.

Requirements

• Bachelor’s degree in science or health science field related to study, or an equivalent combination of related education and experience.
• Minimum of 1 year of clinical research experience.
• Excellent interpersonal, written, and verbal communication skills.
• Knowledge and experience navigating privacy and confidentiality regulations in human subjects’ research.
• Experience managing Institutional Review Board (IRB) regulatory requirements.
• Experience in study protocols and design.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook), Adobe Acrobat.

Qualifications

• Minimum of 1 year of experience in the conduct of human subjects’ research.
• Ability to work occasional nights and weekends due to enrollment protocol requirements.
• Experience in research with both minor and adult study participants.
• Experience with surgical patients.
• Experience with NSQIP, TQIP, NRD, IHA, or other databases.
• Excellent organizational skills to manage several studies simultaneously.
• Knowledge of and experience with RedCap and EndNote.
• Previous experience using Epic for medical chart review and linking subjects to a research study.
• Previous chart abstraction work.
• Knowledge of University policies, procedures, and regulations.

Benefits

• Regular salaried position located in Iowa City, Iowa.
• Fringe benefit package including paid vacation and sick leave.
• Health, dental, life, and disability insurance options.
• Generous employer contributions into retirement plans.

Pay

Pay Grade: 4A

Schedule

Full-time, 40 hours per week with a 30-minute lunch break.