Director, Clinical Research

The University of South Alabama is one of the fastest growing universities in the South, providing quality academic programs, innovative classroom experiences, and a campus rich in diversity and student life.

The Director, Clinical Research, in concert with the Clinical Research Committee, is responsible for the strategic planning, administration, and operation of clinical research activities for the University of South Alabama.  The Director works collaboratively with leadership to establish research priorities and to troubleshoot problem areas; assesses organizational processes associated with clinical research and identifies ways to improve and streamline internal procedures; and ensures internal processes and policies and Standard Operating Procedure (SOPs) are updated according to Good Clinical Practice (GCP) guidelines and ensures internal Quality Assurance standards and practices are in place. The Director will provide oversight, leadership, and guidance in the management and execution of trials. This individual coordinates the efforts of internal and external resources to ensure fast patient recruitment, trial site selection, trial plan optimization, and execution of trials with a focus on quality.

The Director, Clinical Research creates SOPs and builds an infrastructure for facilitation and management of clinical research; serves as a business development liaison with the pharmaceutical industry for pipeline clinical trials; provides updates and status reports to the Clinical Research Committee on a regular basis; develops and maintains professional relationships with academic and community-based physicians, clinicians and investigators; and interfaces with departments within and outside of the University.

Master's degree in a natural or health science related field from an accredited institution as approved an accepted by the University of South Alabama, and ten years of experience in the medical device or pharmaceutical industry, five of which were hands-on managerial experience running clinical trials and managing teams.  Experience with all aspects of management of large clinical trials, from inception to completion, is required.  Strong knowledge of FDA regulations and experience with IDE Trials is required.  Previous clinical trials site management experience is required.  Strong Microsoft Office skills are required.  Knowledge of, and experience in, experimental design, and a basic understanding of statistics and statistical methods, is required.  Knowledge of Good Clinical Practice (GCP) is required.

Strong project planning, leadership, negotiation and presentation skills, as well as an ability to contribute creative yet practical solutions to problems, are required.  Other requirements include extraordinary researching skills and expertise in searching medical literature and databases for clinical and technical information; ability to multi-task and manage several projects in parallel, paying attention to detail; ability to forge cross-functional working relationships with internal teams and external project partners; ability to be proactive in identifying issues and hurdles that may handicap the effective implementation of the trial and resolve the issues in a timely fashion; superior writing skills and ability to effectively communicate with technical and non-technical individuals; and ability to work in a team environment.
 

Monday - Friday
8:00 a.m. - 5:00 p.m.