Louisiana State University Health Science Center – Shreveport is seeking a Director for the Human Research Protection Program (HRPP) and Clinical Trials Management (CTMT) team. The Director will oversee the operations of HRPP and CTMT and provide key leadership to LSUHSC-Shreveport research operations (HSRS). This position requires an individual that can assist the University in its undertaking of initiatives toward enhancing its research infrastructure, programmatic depth, as aligned with the goals of the Human Subject and Clinical Research programs. The Director position will be responsible for oversight and maintenance of institutional policies and procedures that are required to support our Association for the Accreditation of Human Research Protection Programs, Inc., (AAHRPP) accreditation.
The HRPP office supports the regulatory staff and clinical research coordinators of HSRS, the staff of the CTMT, and the LSUHSC-S campus. The office promotes the safety and protection of individuals involved in human subject research by providing support, guidance, oversight, to facilitate ethical and scientifically sound research for Principal Investigators who do not have the staff to serve in these roles through HSRS. The CTMT is responsible for overseeing the financial aspects of clinical trials from the budgeting process to start-up to the end of the trial. The Director is responsible for the review of Confidentiality Disclosure Agreement and Clinical Trial Agreement templates from sponsor/CRO for compliance with federal, institutional and state guidelines and the protocol. The Director provides clear feedback on federal, institutional and state requirements to sponsor/CRO. This position works with the budget coordinator to develop a budget that covers all procedures required by the protocol and compiles and interprets PI, sponsor/designee comments or other contract activities. This position corresponds with researchers and sponsor/CRO and responds to requests for information and gathers information and background material needed to create contracts and complete the budgets. The director submits completed contracts to the sponsor/CRO for signature and ensures that completed contracts are copied, scanned and filed to send to the appropriate parties.
Applicant must meet one of the following qualifications: 1. Master's Degree from an accredited university in business or science with one (I) year of clinical trials experience in an academic or healthcare setting. 2. Bachelor's degree from an accredited university in business or science with three (3) years of clinical trials experience in an academic or healthcare setting.
DESIRED:
Master's Degree in research or business administration
Knowledge of clinical or translation research
Knowledge of regulations and ethical principles regarding clinical research
Understanding of research procedures, research terminology, and research data management.
Familiarity with implementation of protocol processes
Sufficient knowledge of computer uses and applications including word processing programs, spreadsheets and electronic submission systems, and /or databases used to maintain all information pertinent to human subject research.
NOTES:
Employer will assist with relocation costs.
Internal Number: PSN49590
About LSU Health Shreveport
LSU Health Shreveport is an academic health sciences center comprised of three professional schools with the mission to “Teach, Heal and Discover.” Our primary teaching hospitals are located in Shreveport and Monroe and are managed by the Ochsner LSU Health System of North Louisiana. Ochsner LSU Health Shreveport is a tertiary care hospital serving an urban and rural population of approximately 2.5 million, encompassing 25,000 square miles in Louisiana, East Texas, and Southwestern Arkansas.
