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.
Doctoral degree (PhD, MD or DO) in biological or health science field; preferred expertise in immunology and/or cancer research (Required)
Additional graduate degree (masters or PhD) in Clinical Investigation or equivalent program (Preferred)
3 years of post-doctoral laboratory and/or clinical trials experience (Required)
1 year of experience writing and maintaining clinical protocols and documents (such as INDs/IDEs for the FDA) or Regulatory Affairs Certificate (RAC) from RAPS.org or equivalent certification or experience. (Required)
1 year of clinical trial protocol writing experience OR graduate degree in Clinical Investigation or ACRP Certification (CCRA, CCRC, CPI, ACRP-CP or ACRP-MDP). (Required)
Experience in manuscript preparation, submission and presenting results at scientific meetings. (Preferred)
Experience with laboratory analyses of biological specimens via cell culture, flow cytometry, ELISA, in vitro cell function assays or equivalent. (Preferred)