Clinical Research Start Up Specialist

Ann & Robert H. Lurie Children’s Hospital of Chicago provides superior pediatric care in a setting that offers the latest benefits and innovations in medical technology, research and family-friendly design. As the largest pediatric provider in the region with a 140-year legacy of excellence, kids and their families are at the center of all we do. Ann & Robert H. Lurie Children’s Hospital of Chicago is ranked in all 10 specialties by the U.S. News & World Report.

Location Simpson Querrey Biomedical Research Center

Job Description General

Summary:

The Clinical Research Start Up Specialist is an integral member of the Office of Clinical and Community Trials (OCCT). Under the direction of the Director, ROC, the Start Up Specialist is responsible for working together with the Clinical Research Operations Managers, Research Technology Administrator, Sponsors/CROs, Principal Investigators, study teams and ancillary services to provide a smooth and efficient intake process. The Start Up Specialist will assist in shepherding studies from CDA through Epic RSH set‑up including managing study documents, reviewing intake submissions, supporting workflows in the clinical trial management system (CTMS) and confirming appropriate details are added to Epic.

• Supports rapid study start up workflows and the intake of all new clinical research studies to initiate the process for financial and administrative viability review.
• Works closely with all members of Research Operations and Conduct, Clinical Research Support Services, and Clinical Research Finance service lines to assure a smooth process from feasibility to final contract execution for varying funding types.
• Works closely with the Principal Investigator and study staff in coordinating activities and follow-up associated with determining the feasibility of potential new clinical research studies.
• Reviews submitted documents to ensure they contain necessary information and are routed to the proper teams.
• Works within the research technologies, including the CTMS, to tracks dates and statuses throughout start up and confirms dates are entered in the research systems.
• Collaborates with Investigators, study teams, appropriate internal departments, and 3rd party vendors through the startup process to ensure internal and external deadlines are met as well as the needs of the Institution and external funding agencies.
• Communicates with study teams, divisions, ancillary services, appropriate internal departments such as Finance, and 3rd party vendors on the centralized start up process and standardization strategies and processes.
• Ensures that all applicable processes are applied for subsequent protocol amendments with financial and/or billing compliance impact.
• Performs job functions and assigned duties adhering to service principles with customer service focus of innovation, service excellence and teamwork to provide the highest quality care and service to our patients, families, co-workers and others.
• Other job functions as assigned.

• Bachelor’s Degree or three+ years of relevant experience
• One to two years experience in clinical research conduct, clinical research regulatory compliance, clinical research billing, and/or clinical research/trial budget and contract management preferred.
• Understanding of coverage analysis, study budgets, informed consent forms, and CTA cost language preferred.
• Ability to interpret cost language present in the CTA and budget required.
• Ability to interpret research protocol information essential.
• Strong understanding of research billing compliance preferred.
• One to two years of work experience in healthcare finance (patient billing, collections, account reconciliations, etc) preferred.
• Wo…