· Administers Phase One treatments under direction of Director of Clinical Trials.
· Identifies and evaluates patient eligibility through records review and consultation with physicians to verify each patient's appropriateness for entry into protocols, assists with the randomization process, and obtains written informed consent from the patient.
· Submits approved protocols, amendments, notices, suspensions, and terminations to the IRB for review, approval, and re-approval.
· Maintains an administrative file on all protocol documents, trial sponsor correspondence, and IRB correspondence, as well as maintains and monitors patient case records for accuracy, quality of data, and compliance with protocol guidelines.
· Responsible for reporting all adverse drug reactions according to the guidelines of the National Cancer Institute (NCI), Food and Drug Administration (FDA), trial sponsors, the IRB, and other regulatory bodies as required.
· Provides internal and external community education regarding available trials as needed.
· Provides monthly statistical reports on current and available trials including information on active protocols, number of patients enrolled, adverse events and IRB status.
Knowledge, Skills and Experience Required:
- Demonstrated knowledge about and/or experience with Clinical Trials Required
- BSN Required
- Background in Statistics preferred
- Prior experience in Oncology preferred