The Scientist participates in the development and writing of investigator-initiated clinical cancer trials and be the primary individual responsible for submission of these protocols (and their reports/renewals and related correspondence) to regulatory agencies (such as the US FDA). In addition, the Scientist oversees the performance and analyses of ancillary biological studies to achieve the scientific aims of those clinical trials, analyze collected lab and clinical data and serve as a co-investigator/co-author for publications related to these clinical trials. The overall aim of the clinical research initiatives in the Division of Pediatric Hematology, Oncology, and Bone Marrow Transplant (The Division) is to improve outcomes for children with cancer and non-malignant hematologic diseases.
- 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.
Protocol Development and IRB Application and Compliance
- Protocol development/writing working closely with the PIs.
- Preparation, submission and continuing reviews for IRB applications for biological studies on human specimens (e.g., tissue, cells).
- IRB application and amendment preparation oversight and annual renewals for clinical studies and laboratory-based IRB approvals required for immune monitoring on samples obtained from human subjects participating in clinical trials.
- Preparation for internal/external compliance reviews (e.g., IRB, FDA).
- Case Report Form development.
- Standard Operating Procedures preparation (for clinical trial ancillary biological studies, if applicable).
- Work with other scientists and research associates within the laboratory and clinical team on research aspects and clinical monitoring aspects to ensure compliance and laboratory regulatory requirements are adequate, current and practiced/maintained within the laboratory.
- Supervise research associate in the organization, conduct and record keeping of all laboratory monitoring results.
IND/IDE Preparation and Submission
- IND/IDE application preparation and submission to the FDA.
- IND/IDE maintenance including amendments, safety reports, and annual reports.
Publication/Grant Writing and Submission including Data Analysis and Compilation
- Work with other researchers and PIs in the Division to prepare data for publication and assist as co-author of publications regarding clinical trials.
- Function as a co-investigator on grant submission and conduct for grants related to clinical trials and analyses of lab specimens from clinical trials.
- Preparation of PRS (Protocol Registration and Results System) documents for ClinicalTrials.gov.
- Assist in data analysis of Clinical Trial ancillary biological studies (when applicable).
- Assist in data analysis of Clinical Trial outcome measures.
Oversight of Patient Samples
- Ancillary Biological Study Kit preparation; scheduling and retrieval of patient research samples (when applicable).
- Supervision of Clinical Trial Subject research specimen processing (when applicable).
- Performs miscellaneous job related duties as requested.