Clinical Trials Research Asst/Data Management - Department of Surgery

Clinical Trials Research Asst/Data Management - Department of Surgery Position Summary The clinical trial research assistant/ data manager will be an integral member of the research team in Dr. Vikas Dudeja’s lab in the Department of Surgery and will have a strong collaborative relationship with the Institute for Clinical and Translational Science team. The clinical trial research assistant/ data manager will apply clinical skills to administer, deliver, and evaluate research protocols. Key Areas of Responsibilities and Specific Job Tasks Research/Clinical Activities; Subject Recruitment and Enrollment Perform clinical/health care research activities. Screen, recruit, enroll and obtain informed consent for clinical research activities. Educate patient scope of study, potential risks and benefits, possible alternative, and study requirements for patient. Relay information to principal investigator and verify patient eligibility. Oversee the recruitment of subjects and scheduling of trial-related procedures. Prepare study recruitment materials. Protocol Development/Management and Study Responsibilities Assist in the design, development, execution, administration and maintenance of protocols and clinical studies and provide input into descriptions of complex research procedures. Assist patents with problems related to protocol. 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. Data Collection and Monitoring Participate in the design; development and testing of clinical research trial data systems. Acts as a liaison between health care information systems and research data systems. Validate data and make recommendations for resolution. Regulatory Guidelines and Documents Manage and organize regulatory documentation. Prepare regulatory submissions. Preform on-site audits of research and clinical data. Monitor compliance of regulatory guidelines and proper maintenance of documents. Prepare and present Institutional Review Boards or other submissions and required regulatory documents. Assist with IRB, ACURF or similar protocol submissions. Participate in preparation of grant applications for extramural funding. Provide assistance with tracking and reconciling grant/trial budget free balances and identify opportunities to ensure that grant funding is being used as intended and awarded. 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%, 40 hours per week Schedule: 40 hour week with a 30 minute lunch Location: University of Iowa Health Care Medical Center on the University Campus Pay Grade: 3A 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. For more information on benefits, please visit: Education A Bachelor’s degree in a Health Science field or an equivalent combination of education and research experience is required. Experience Requirements Excellent written and verbal communication skills are required. Ability to work nights and weekends is required. Proficiency in Microsoft Word, Outlook and Excel is required. Desired Qualifications Basic clinical research experience is desirable. Working knowledge of Good Clinical Practice (GCP) is desirable.?? Previous experience writing manuscripts for publication is desirable. Experience with REDCap, Epic, I-CART, and ACCESS is desirable. Previous experience in data collection and entry is desirable. Experience in processing research regulatory documents is desirable. A current license to practice nursing in Iowa by the time of hire is desirable. The ability to work independently is desirable. Excellent time management skills and ability to perform detail-oriented work is desirable. 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 View email address on click.appcast.io Additional Information Appointment Type: Professional and Scientific Schedule: Full-time Work Modality Options: On Campus Compensation Contact Information Contact Name: Devin DeAnda Equal opportunity employer The University of Iowa is an equal opportunity 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, 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, View phone number on click.appcast.io or View email address on click.appcast.io . For jobs in UI Health care, please contact UI Health care Leave & Disability Administration at View phone number on click.appcast.io . #J-18808-Ljbffr The University of Iowa