Clinical Trials Research Associate - Acute Care Surgery
The Clinical Trial & Data Management Research Associate will conduct and manage clinical trials within the parameters of applicable study protocols for Acute Care & Trauma surgery patients. Screen for eligibility, recruit, consent, and monitor research subjects. Maintain databases related to above studies. Communicate concerns to primary investigators and, if instructed, to the IRB and study sponsor. Maintain case report, other studies, and institutional review forms in a timely and accurate fashion. 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.
- Have a thorough knowledge of study protocols and design.
- Be well versed in IRB procedures and policies.
- Communicate protocol deviations and concerns immediately to PI.
- As skills develop, troubleshoot, and analyze protocols; propose modifications to collaborative researchers or principal investigator.
- Maintain study data and records.
- Prepares monthly research progress reports updating progress and attends weekly divisional research meetings.
- 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.
- 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.
- Screen electronic medical records daily.
- Assess patients’ eligibility for all ongoing trials.
- Communicate effectively with PI to confirm eligibility.
- Approach subjects and/or legal authorized representative to discuss study.
- Consent and enroll subjects per study protocol.
- Experience with EPIC electronic medical record system is preferred.
- Enter clinical data in clinical research database in a timely manner post-subject recruitment.
- Answer all sponsor’s or CRO ‘s queries in a timely manner and accurately.
- Support the development of REDCap databases for investigator-initiated clinical studies.
- Verify data entry and maintain databases.
- Prior knowledge and experience with database development such as REDCap is highly recommended.
- 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 event.
- Present new study protocols to the Acute Care Surgery faculty as needed.
- Provide training as needed to the Acute Care Surgery faculty and associated staff regarding research related clinical activities and protocols.
- Present new study protocols to staff as needed.
- Ensure that human research subject training is up to date for all faculty and staff involved in studies.
- Support Associate research scientist in negotiating budgets for clinical studies with sponsors.
- Communicate effectively with sponsors.
- Assist with procurement and storage of supplies and materials.
- May initiate purchasing requests, monitor accounts/expenditures; reconcile statements.
- 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.
Department Summary: The UI 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 - Friday: 8am - 5:00pm
Location: UIHC Main campus
Pay Grade: 4A Pay Structure A
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: UIHC Benefits
- For more information about Why Iowa?, click here
Required Qualifications:
- A Bachelor's degree or an equivalent combination of education and experience.
- Thorough knowledge of study protocols and design as well as IRB procedures and policies is required.
- Excellent written, verbal communication, interpersonal, and organizational skills are required.
- 1-year experience enrolling patients and monitoring study patients as required by protocol is required.
- Knowledge of regulatory guidelines and procedures as set forth by the IRB and/sponsoring agencies.
Highly Desirable Qualifications:
- Prior knowledge and experience with Office 365, REDCap, EPIC, and EndNote.
- Experience managing complex information requiring attention to detail.
- Knowledge of medical record coding practices, procedures, and reference sources.
- Ability to interpret guidelines, criteria, and definitions.
- 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.
- Ability to fluctuate occasionally working nights and weekends due to requirements of enrollment protocol of the study.
- Experience with Surgical procedures.
Desirable Qualifications:
- Knowledge of University of Iowa policies, procedures, and regulations.
- Previous database experience.
- Previous chart abstraction work.
Application Process: In order to be considered for an interview, applicants must upload the following documents and mark them as a "Relevant File" to the submission:
- Resume
- Cover Letter
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 Jordan Adam at 319-384-6144 or jordan-adam@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, national origin, age, sex, pregnancy, sexual orientation, gender identity, genetic information, religion, associational preference, status as a qualified individual with a disability, or status as a protected veteran. The University also affirms its commitment to providing equal opportunities and equal access to University facilities. Women and Minorities are encouraged to apply for all employment vacancies. For additional information on nondiscrimination policies, contact the Coordinator of Title IX and Section 504, and the ADA in The Office of Equal Opportunity and Diversity, 319/335-0705 (voice) or 319/335-0697 (text), The University of Iowa, 202 Jessup Hall, Iowa City, Iowa, 52242-1316.
Persons with disabilities may contact University Human Resources/Faculty and Staff Disability Services, (319) 335-2660 or fsds@uiowa.edu, to inquire or discuss accommodation needs
