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 patient's 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 state's 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.
- For more information about Why Iowa? click here.
Required Qualifications:
- 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 of and experience navigating privacy and confidentiality regulations in human subjects' research.
- Experience managing IRB regulatory requirements.
- Experience in study protocols and design.
- Proficiency in Microsoft Office Word, Excel, PowerPoint, and Outlook and Adobe Acrobat.
Desired Qualifications:
- 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.
Application Process: In order to be considered for an interview, applicants must upload a resume and cover letter and mark them as a "Relevant File" to the submission.
Job openings are posted for a minimum of 14 calendar days and may be removed from posting and filled any time after the original posting period has ended.
Successful candidates will be required to self-disclose any conviction history and will be subject to a criminal background check and credential/education verification.
Up to 5 references will be requested at a later step in the recruitment process. This position is not eligible for University sponsorship for employment authorization.
For additional questions, please contact Katie Pontious-Vanhxay at (319) 384-6144 or Katie-Pontious-Vanhxay@uiowa.edu.
Equal opportunity/affirmative action employer
The University of Iowa is an equal opportunity/affirmative action employer. All qualified applicants are encouraged to apply and will receive consideration for employment free from discrimination on the basis of race, creed, color, religion, national origin, age, sex, pregnancy (including childbirth and related conditions), disability, genetic information, status as a U.S. veteran, service in the U.S. military, sexual orientation, gender identity, or associational preferences.
Persons with disabilities who need assistance or accommodations with the application or interview process may contact University Human Resources/Faculty and Staff Disability Services, (319) 335-2660 or fsds@uiowa.edu. For jobs in UI Health care, please contact UI Health care Leave & Disability Administration at 319-356-7543.
