May assist with clinical and data coordination for research activities. May screen, recruit, enroll and obtain informed consent for clinical trials.
Assists Pediatric Surgery faulty in the conduct of clinical trials by managing the clinical trials and pediatric surgery data within the parameters of study protocols for pediatric surgery patients. Ability to collaborate with other researchers and investigators emphasized.For prospective clinical studies: Recruit and enroll participants, ensuring all the prerequisites are complete and conform to required parameters. Explain study to participants/family and assist in obtaining consent to be enrolled in protocol. Responsible for scheduling 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. Counsel the participants/ family regarding the intent of the study. Prepare and present educational materials for participants and other staff to carry out protocol as needed.
Protocol Development/Management & Study Responsibilities:
Consult with researchers to assist in developing a data management plan; design forms to facilitate the collection and tracking of study participant data, study drugs, biological specimens and study procedures. Design and coordinate field tests for data collection forms and assisting in design of certification procedures
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. Prior knowledge and experience with RedCap and EndNote helpful but not required.
Data Collection & Monitoring:
Collect and enter clinical research data required by the sponsors in a timely manner. Assist with determining validity of data obtained.
Assist in the preparation, calibration, and maintenance of any necessary equipment. Assist with procurement and storage of supplies and materials. May initiate purchasing requests, monitor accounts/expenditures; reconcile statements.
May provide functional and/or administrative supervision. Mentor new staff under direction.
Provides training as needed to the Pediatric Surgery faculty and associated staff regarding research related clinical activities and protocols.
Regulatory Guidelines and Documents:
Conduct audit to assess quality assurance. Develop procedures for on-site data audits; participate in audits; design and generate reports for use in data audits; summarize results of audits and write reports.
Positive Impact/Achieving Results
Ability to utilize existing resources and learning to achieve or exceed desired outcomes of current and future organizational goals/needs. Able to demonstrate ethical behavior in diverse situations while producing results.
Service Excellence/Customer Focus
Ability to meet or exceed customer service needs and expectations and provide excellent service in a direct or indirect manner. Ability to effectively transmit and interpret information through appropriate communication with internal and external customers.
Collaboration and Embracing Diversity
Ability to work with a variety of individuals and groups in a constructive and civil manner while appreciating the unique contribution of individuals from varied cultures, race, creed, color, national origin, age, sex, disability, sexual orientation, and gender identity.
Knowledge of formal methodologies, tools and techniques for conducting research, studies and tests.
Knowledge of and the ability to locate, interpret and evaluate research findings compiled and documented by others and use this material to support empirical research.
Knowledge of and ability to utilize tools and techniques for producing well-written, meaningful and usable documentation of research findings.
Knowledge of practices, behaviors, applicable laws, rules, and regulations governing proper research conduct, ability to demonstrate ethical and compliant behavior in diverse situations.
Knowledge of the procedures and programs in place in the organization to ensure employee, student and subject safety (occupational safety, fire, patient, animal, drug, radiation, environmental safety and emergency plans), ability to train others; ability to take appropriate actions in case of emergency.
With over 31,000 students, the University of Iowa is one of the nation's top public research universities, a member of the Big Ten conference and the Association of American Universities. The University of Iowa is composed of eleven colleges and is known around the world for its balanced commitment to the arts, sciences, and humanities. It is home to one of the nation's largest academic medical centers and the pioneering Iowa Writers' Workshop. The University of Iowa promotes work/life integration and is located in the casual yet cosmopolitan environment of Iowa City, widely recognized as one of the country's most livable communities.