Manage and conduct clinical trials for the Burn Surgery division, including screening, recruiting, and monitoring research subjects. Coordinate with study sponsors, maintain regulatory documentation, and manage study budgets and data systems.
Requirements summary
Requires a Bachelor's degree in a STEM field and 2 years of clinical research experience. Must have knowledge of regulatory guidelines (GCP, IRB) and proficiency in Microsoft Office.
University of Iowa Health Care, Department of Surgery is seeking a Clinical Trials Research Associate to conduct and manage clinical trials within the parameters of applicable study protocols for the Burn Surgery division.
Screen, recruit, consent, enroll, and monitor research subjects.
Maintain databases related to above studies.
Communicate concerns to primary investigators and as needed to the IRB and study sponsor.
Maintain case reports and other study and institutional review forms in a timely and accurate fashion.
Partner with study sponsors regarding protocols, outcomes, and budgets.
Organize multiple studies and manage a large portfolio of information.
Support Burn Surgery divisional faculty in research and educational efforts.
Maintain study budget documents and keep study payments up to date.
Develop study materials and suggest enhancements to study protocols and processes.
Evenings and weekends may be necessary based on clinical trial protocols or patient enrollment duties.
Key Areas of Responsibilities and Specific Job Tasks
Protocol Development/ Management and Study Responsibilities
Assist in the design, development, execution administration and maintenance of protocols and clinical studies. Assist in study design and protocol development and provide input into descriptions of complex research procedures. Oversee CRF development. Review query reports. Resolve all monitoring visit issues. Perform and monitor randomizations. Develop complex study materials. Serve as liaison to local health care practitioners, agencies, and sponsors. Research/ Clinical Activities;
Subject
Recruitment and
Enrollment: Screen, recruit, enroll and obtain informed consent for clinical trials. Oversee the recruitment of subjects and scheduling of trial-related procedures. Educate study participants on scope of study, potential risks and benefits, possible alternatives, and study requirements for participants. Relay information to PI and verify study participant eligibility.
Data
Collection &
Monitoring: Participate in the design, development and testing of clinical research trials data systems. Validate data, query resolution and make recommendations for resolution. Revise and implement change in data collection
Human
Benefits
Dental Insurance
Disability Insurance
Life Insurance
Sick Leave
Health Insurance
Paid Vacation
Retirement Plans
Resources/Leadership: May provide functional and/or administrative supervision. Mentor new staff under direction.
Regulatory
Guidelines and
Documents: Manage and organize regulatory documentation from sites and regulatory authorities. Prepare regulatory submissions. Perform on-site audits of research and clinical data. Monitor compliance of regulatory guidelines and proper maintenance of documents. May recommend corrective action for reportable evens. May communicate with IRB staff and investigators.
Financial
Responsibility: Administer and/or monitor budget for studies.
Type of
Position: Specified Term. Initial appointment is for one year. Appointment may be extended based on performance and availability of funding.
Percent of
Time: 100%25, 40 hours per week
Schedule: 40 hour week with a 30 minute lunch
Location:
UI
Main campus
Pay
Grade: 4A
Benefit
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.
Qualifications: Bachelor’s Degree in a STEM (Science, Technology, Engineering, or Math) or related educational field with 2 years of clinical research experience or an appropriate combination of previous educational and clinical/research experience. Excellent written and verbal communication skills. Proven interpersonal and organizational skills. Ability to fluctuate occasionally working nights and weekends to enroll patients and/or monitor study patients as may be required by the enrollment protocol of the study. Experience working with patients in a hospital or clinical setting including providing care and reviewing medical information. Ability to work independently and manage multiple priorities or studies at one time. Knowledge of regulatory guidelines and procedures (Belmont Report, Helsinki ethical principles for medical research involving human subjects, good clinical practice, responsible conduct of biomedical research) as set forth by the IRB and/sponsoring agencies. Knowledge of Microsoft Office
Word,
Excel,
PowerPoint,
Outlook,
Adobe
Acrobat
Desired
Qualifications: Experience with surgical patients, phlebotomy and wound care Recent (within the last 5 years) experience working with Clinical Trial protocols Experience with Surgical procedures. Previous experience with research subject recruitment Previous experience in a role requiring independent decision making and proven follow through. Prior knowledge and experience with RedCap and EndNote. Previous experience using EPIC for medical chart review and linking subjects to a research study.
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 7 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 kiley-skay@uiowa.edu
