The Executive Director of Clinical Research for The Big Idea Epidural Stimulation initiative will direct multiple clinical research projects and work collaboratively with investigators and collaborators to facilitate the establishment and successful management of The Fake Watches Big Idea at the University of Louisville.
Provide programmatic leadership and input for all strategic plan implementation processes. Develop, establish and direct execution of operating policies, clinical protocols and performance goals to support overall objectives.
Oversee the daily operations of epidural stimulation for cardiovascular recovery after spinal cord injury, including business and clinical functions, faculty and staff recruitment and retention.
Ensure that the appropriate administrative, regulatory and financial deliverables are met on a timely basis; and ensure the Principal Investigator and the Reeve Foundation are fully apprised of progress in these arenas.
Form and convene a Data & Safety Monitoring Board (DSMB). Establish a schedule for formal reporting of data and progress of epidural stimulation for cardiovascular recovery after spinal cord injury investigations team to DSMB and Reeve Advisory Board. Provide ongoing analysis, monitoring and forecasting.
Work closely with The Big Idea Epidural Stimulation initiative co-investigators,omega seamaster aqua terra replica collaborators, Advisory Board, and consultants to ensure success of the project.
Work in partnership with KYONE health administrators and in consultation with the Principal Investigator and Reeve Foundation to negotiate hospital, surgical and clinical costs for epidural stimulation for cardiovascular recovery after spinal cord injury.
Establish Memoranda of Understanding between all collaborators for The Big Idea Epidural Stimulation initiative.
- Facilitate and as appropriate draft the various documents and materials that may be associated with the project, including but not limited to the protocol, DSMC charter, authorship policy, IRB consent form, data monitoring/analysis plan, manual of operations, adverse event medical management plan.
- Work with PI and co-investigators to identify and screen potential subjects, ensuring that subjects are screened in a consistent manner. Ensure inquiries into the program are referred to appropriate resources for potential inclusion in project.
- Research and develop subject reimbursement options for medical follow-up visits after completion of epidural stimulation for cardiovascular recovery after spinal cord injury study.
- Develop adverse event protocols within KYONE health care system. Oversee and document all research related medical issues.
- Conduct reviews of clinical research for The Big Idea Epidural Stimulation initiative and oversee quality assurance of protocols.
- Liaise with the health economist leading the healthcare resource utilization sub study; responsibilities will include but not be limited to support finalizing the economics budget and the data collection plan.
- Ensure seamless coordination between the health economist, the Principal Investigator, Reeve Foundation and clinical research coordinator.
- In concert with Principal Investigator and Neuroscience Collaborative Center Program Manager, ensure proper allocation and utilization of all resources for project.
- In concert with Reeve Foundation Executive Vice President, and Program Manager, ensure Reeve Foundation has the financial materials it needs to fulfill its reporting obligations to the Reeve Foundation Board of Directors, donors, other and epidural stimulation for cardiovascular recovery after spinal cord injury donors.
- Establish publication policies and develop a publication strategy and timeline. When appropriate, facilitate and coordinate manuscript drafting and publication efforts between/among the experimental groups, the individual investigators and the Principal Investigator.
$90K - $105K