Nurse Research Associate / ACCM

Nurse Research Associate I - Anesthesiology Critical Care Medicine (ACCM) Position Purpose and Summary: To manage all aspects of clinical trials underway as well as those from inception. Monitor study patients and provide appropriate nursing services; review and evaluate health status, lab findings and reactions; oversee accurate records, maintain and implement research protocols, develop policies and procedures and submission of trials to the IRB. Duties and Responsibilities: Analyzes and abstracts data from departmental and medical record charts for completion of all Phase I, II, III and Pharmaceutical study case report forms, including documentation of therapy received, disease response, laboratory data, and toxicity. Completes report forms prior to submission to the Sponsor. Ensures completion and submission of all case report forms by deadlines imposed by regulatory agencies. Assists members of the health care team by providing knowledge of assigned protocols with regard to patient eligibility, required specimens and tests, therapy, toxicity modifications, etc. Verifies patient eligibility and registers all eligible patients with appropriate center and randomizes patients as necessary. Maintains documentation of patient registration and other required study paperwork. Participates in internal and external audits of assigned protocols. Takes a leadership role in the preparation for internal/external audits. Assists Clinical Trials Management Team in the execution of internal audits. Participates in team conferences in order to update research team regarding patient protocol status, toxicity, eligibility, randomizations and specimens. Communicates with research team to ensure all protocol related policies and procedures are followed appropriately. Works with physician investigators and Nurse/Case Managers to ensure timely and accurate reporting of all Adverse Drug Reactions and Adverse Events. Assists local investigators with institutional protocol development and implementation, including review of protocol documents, case report form creation, database development, and monitoring of outside participating institutions. Assists physician investigators and the IRB Specialist with preparation of informed consents and protocol summaries, and with submission of local and cooperative protocols to the IRB. Coordinates collection and shipment of all protocol required microbiology specimens, Pharmacokinetics, scans, and educational materials. Maintains related computerized databases by entry of required patient demographic, protocol, clinical, laboratory, and form tracking data. Attends Division meetings, ACCM Conferences and other position related CHLA educational meetings. Attends investigator meetings for new studies Demonstrates behaviors that support performance improvement activities. Maintains competence and professional development. Maintains license, certification or registration as required. Performs other duties as requested.