This position assists in the coordination of various research projects and supports the Principal Investigator and other Clinical Research support staff in the acquisition of specimens and extraction of data from patient charts. This position also provides administrative/regulatory support by assisting with patient recruitment; scheduling study participants; providing operational support for the implementation and delivery of research studies; maintaining complete and accurate data and source documentation; and processing IRB and other regulatory documents as needed in accordance with federal, state, and regulatory agency and local 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.
- Assists with completion of all study documentation forms, including case report forms and other study specific documents. Maintains complete and accurate regulatory documentation and subject data.
- Ensures assigned studies are conducted in accordance with the Food and Drug Administration (FDA), Office for Human Research Protections (OHRP), Good Clinical Practices (GCP), and institutional guidelines.
- Maintains knowledge and understanding of assigned protocols, including all protocol requirements for patient visits. With specific training and approval from the Director, Clinical Research Operations, assists in obtaining informed consent for non-interventional studies.
- Reviews and responds to all regulatory requirements for all study protocols; assists with all required forms/documents for initial study with IRB.
- Schedules medical procedures/tests necessary for research, including blood draws and imaging studies.
- Supports the investigator in recruitment and selection of study participants.
- Performs miscellaneous job related duties as requested.