Clinical Trials Research Asst/Data Management - Department of Surgery
Description
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.
Financial Responsibility
- 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: [click to reveal website link]
Qualifications
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.
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 [click to reveal email address]