Clinical Trials Research Assistant - Department of Surgery

University of Iowa•Iowa City, IA

5d•Onsite

About The Position

The Clinical Trial & Data Management Research Assistant will directly conduct and manage sponsored and non-sponsored clinical trials and studies within the parameters of applicable study protocols for Acute Care Surgery patients. This position will screen for eligibility, recruit, consent, and monitor research subjects; maintain case reports and databases related to above studies; communicate concerns to primary investigators and, if instructed, to the IRB and study sponsor; and review study budget documents and keep study payments up to date. It is possible that due to enrollment protocols that work hours could be during evening, night, or weekends. Ability to collaborate with other researchers and investigators emphasized. This individual should have a thorough knowledge of study design and protocols and be well versed in IRB procedures and policies. This individual will be involved in research subject recruitment involving emergency general surgery, ICU, trauma, and burn patients. Empathy, patience, and excellent communication skills are required.

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.

Nice To Haves

Minimum of 1 year of experience in the conduct of human subjects’ research.
Ability to fluctuate occasionally working nights and weekends due to requirements of enrollment protocols of studies.
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 as this position requires the individual to manage several studies at once.
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.

Responsibilities

Assist Acute Care Surgery faculty in the conduct of clinical trials by managing the clinical trials as well as acute care and trauma surgery data within the parameters of study protocols for applicable surgery patients.
Recruit and enroll participants, ensuring all the prerequisites are complete and conform to required parameters.
Explain study and study intent to participants/family and assist in obtaining consent to be enrolled per study protocol. Consent and enroll subjects per study protocol.
Schedule participants for procedures or follow up as required by the study protocol or design; arrange for follow-ups with study participants and maintain records of their visits and interviews.
Prepare and present educational materials for participants and other staff to carry out protocol as needed.
Communicate protocol deviations and concerns immediately to PI. As skills develop, troubleshoot and analyze protocols; propose modifications to collaborative researchers or PI.
Maintain study data and records.
Prepare monthly research progress reports updating progress and attends weekly divisional research meetings.
Screen electronic medical records daily to recruit and enroll participants and assess patients’ eligibility for all ongoing trials.
Assist in the preparation, calibration, and maintenance of any necessary equipment.
Assist with procurement and storage of supplies and materials.
May initiate purchasing requests, monitor accounts/expenditures; reconcile statements.
Maintain all regulatory documents for each trial following University policy.
Update regulatory binders as needed.
Prepare documentation related to reportable events. Provide IRB and sponsor with any information related to reportable events.
Present new study protocols to the Acute Care Surgery faculty and staff as needed.
Provide training as needed to the Acute Care Surgery faculty and associated staff regarding research related clinical activities and protocols.
Ensure that human research subject training is up to date for all faculty and staff involved in studies.
Support in negotiating budgets for clinical studies with sponsors.
Communicate effectively with sponsors.
Reconcile invoices and payment to ensure all study-related costs are paid for.
Reconcile payment in the University of Iowa I-CTMS subject tracking system.