Clinical Trials Research Assistant - Dept of Surgery - EGS/Trauma

The Clinical Trials & 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 Institutional Review Board (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 evenings nights 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.

• 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.
• Communicate protocol deviations and concerns immediately to the Principal Investigator (PI). As skills develop troubleshoot and analyze protocols; propose modifications to collaborative researchers or PI.
• Maintain monthly study data and records. Prepare monthly research progress reports updating progress and attending weekly divisional research meetings.
• 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 staff regarding research related clinical activities and protocols.
• Reconcile invoices and payments to ensure all study-related costs are paid for.
• Support in negotiating budgets for clinical studies with sponsors.

Department of Surgery: The University of Iowa Health Care Department of Surgery is committed to saving lives and improving our patients quality of life through excellent surgical techniques and extraordinary patient care. Our surgeons and medical professionals address a wide variety of complex medical issues from matching donors with recipients in the Organ Transplant Center to providing continuous care for both adult and pediatric trauma victims in the states only designated Level I Trauma Center and certified regional Burn Treatment Center.

Percent of Time: 100%

Schedule: Monday through Friday 8:00 am to 5:00 pm. It is possible that due to enrollment protocols that work hours could be during evenings nights or weekends.

Location: UI Health Care Medical Center University Campus

Pay Grade: 3A Pay Structure

Benefits Highlights:

• Regular salaried position located in Iowa City Iowa.
• 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 on benefits please visit UI Health Care Benefits.
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