Phoenix Childrens Hospital. - Phoenix, AZ
This position coordinates a variety of research projects and will work independently in the acquisition of specimens, extraction of data from patient charts, and analysis of data per protocol as well as administrative / regulatory support (recruiting, interviewing and scheduling study participants, processing IRB and other regulatory documents) to specific clinical departments in accordance with all federal, state, and regulatory agency requirements and specific institutional requirements.
Family-Centered care that focuses on the need of the child first and values the family as an important member of the care team
Excellence in clinical care, service and communication
Collaborative within our institution and with others who share our mission and goals
Leadership that set the standard for pediatric health care today and innovations of the future
Accountability to our patients, community and each other for providing the best in the most cost-effective way.
Ensures assigned studies are conducted in accordance with the Food and Drug Administration (FDA), Office for Human Research Protections (OHRP), and Good Clinical Practices (GCP) guidelines, which includes the following duties. Reviews all regulatory requirements to ensure implementation of appropriate methods, practices, procedures, and protocols for all research activities in noted area
Completes all IRB required paperwork for studies
With the principal investigator, explains the study purpose, parameters, and requirements of the studies to the participants
Completes all tasks required by study sponsors. Provides regulatory documents to sponsor in timely manner
Completes case report forms for all study participants
Tracks and reports adverse events
Coordinates research monitor visits
Coordinates the process for opening new studies. Obtains needed background material(s) on proposed research projects; presents findings and information to attending physician/principle investigator
Completes feasibility questionnaires
Circulates the confidentiality disclosure and trial agreements to the appropriate parties
Reviews monthly financial reports, including study participant billing, expenditures, and revenue. Prepares budget analysis form according to study protocol procedures
Participates in recruitment and selection of medical study participants by interviewing and reviewing medical history to determine compliance with eligibility requirements.
Coordinates and schedules a variety of medical tests including, but not limited to, blood draws, blood pressure readings, imaging studies, and cardiac and/or pulmonary function tests, as needed to establish initial patient baselines for study.
Provides patient education regarding the study-to-study participants and families to ensure understanding or proper medication dosage, administration, and disease treatment.
Maintains inventory level of all supplies and equipment, initiates requisitions for replacement items, and maintains equipment to provide for continuous operational efficiency.
Participates in a variety of professional development programs to ensure understanding of most current methodologies, practices, and philosophies as applied to the relevant patient population and research area.
Performs miscellaneous job related duties as requested.