Utilizes broad-based knowledge of the industry, company and function to contribute to and support the clinical studies department’s mission to pursue profitability and growth while advancing the science of renal disease therapy and improve patient lives. Defines, implements and maintains effective governance and financial principles, processes and procedures within the clinical studies department.
Responsible for assisting with process improvement and serving as the internal quality contact and resource for the department to support quality initiatives and projects. Duties include monitoring and modifying procedures for quality management, developing a calendar for monitoring quality indicators, providing routine reporting of variances to directors and other appropriate personnel and more.
Supports contract research activities by providing oversight and monitoring of clinical trial activities at numerous investigative sites. Provides progress summary reports to clients, project personnel and management. Participates in investigator recruitment and the locating of feasible study sites. Ensures all research activities receive appropriate institutional review board (IRB) approval and more.
Assists in efforts to optimize the management and oversight of clinical trials in the chronic kidney disease (CKD) and end stage renal disease (ESRD) arenas, as well as the bioinformatics and analytics program. The scope of clinical data analysis includes execution of study- and facility-specific queries to determine potential study feasibility, aid with site selection and assist with identification of potential research subjects.
Supports the research approval process designed to improve communication between the field and corporate office with regard to clinical trials, and monitors all studies that are being conducted within FMCNA dialysis facilities. This oversight will ensure research is conducted in compliance with federal guidelines, that there is no inappropriate billing of study services or supplies and that overhead fees and lost revenue associated with these projects are recouped.
Responsible for clinical and nonclinical regulatory documents (e.g., study protocols, investigator brochures, clinical study reports, annual reports, investigational new drug applications, new drug applications) as well as clinical and nonclinical publications (e.g., abstracts, posters, manuscripts).
Manages and plans regulatory compliance for industry sponsors and/or sites in networks. Works closely with the regulatory management and department director and/or primary investigators to ensure compliance, and prepares for auditing activities while meeting strict deadlines.
Responsible for ensuring appropriate statistical techniques are used to safeguard the scientific validity and overall quality of clinical trial results. Performs statistical analysis, contributes statistical input when requested and represents Frenova’s biostatistics function to external partners.
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