USA Health helps people lead longer, better lives through its excellence in education, research and medical care. With more than 3,600 employees, USA's health network includes University Hospital, Children's & Women's Hospital, Mitchell Cancer Institute, Physicians Group, and the College of Medicine. Each year, our team of 180 physicians, 240 residents and fellows, 70 advanced practitioners and 800 nurses handle some 185,000 clinic visits and 350,000 outpatient procedures. USA Health delivers 2,800 babies a year, more than any other regional hospital, and treats patients through some 60,000 emergency room visits annually.
In addition to advanced and innovative patient care offered at University hospitals and clinics, USA's medical education programs provide first-class training experiences for the next generation of physicians and scientists. USA Health delivers excellence in care while improving the quality of life for residents across the Gulf Coast.
USA Health is managed by the USA HealthCare Management, LLC.
Works with the USA Health Clinical Trials Office (CTO) Finance Unit to ensure clinical trial budgets, contracts and informed consents for each trial are congruent; ensures all required approvals are in place before subject recruitment and/or enrollment on new trial(s); ensures timely reporting of adverse events, protocol deviations and serious adverse events to internal IRB, external IRB and trial sponsor; reviews safety reports for each trial and communicates to Principal Investigator and other pertinent individuals in a timely manner; ensures resolution of data queries are done in a timely manner; maintains standardized process for clinical trial recruitment, screening, enrollment and retention of participants into clinical trials within the USA Health CTO; ensures timely IRB submission(s) for new trials, annual renewals and protocol amendments; maintains weekly/monthly IRB status reports and generates clinical trial specific enrollment reports as needed; provides data sets/reports for but not limited to: disease specific population(s), enrollment and open/pending/hold/closed trials; develops enrollment monitoring and reporting plan for human subject clinical trials; organizes and leads meeting(s) for regulatory planning, development and implementation of new protocols; ensures that USA clinical trials open to enrollment and trial related information on the USA Clinical Trial Office website and smart phone app are up to date at all times; ensures that all principals of good clinical practices (GCP) in clinical trials and all other required education and/or training of staff and physicians is up to date; manages process for study start up and site initiation visits; maintains standardized process for scheduling and hosting monitor visits.
Works with clinical applications team to ensure all trials are entered and maintained in the electronic medical record; implements a standardized process for review of regulatory binders, binder maintenance and/or electronic access for external review; manages all aspects for end of trial close out; supports investigator initiated research by assisting in the development of regulatory related protocol information and consent development; assists with protocol submission and information queries from Institutional Review Board; assists researchers in retrieving information from databases and other multiple data sources to support protocol development and IRB information queries; works with the Office of Research Compliance and Assurance to facilitate internal audits and audit actions plans to ensure USA Health CTO clinical trial(s) compliance; oversees day to day activities of the USA Health CTO Regulatory personnel; assists in standardizing procedures for the quality assurance of all study databases; assists in the planning and formulation of policies, objectives and strategies for delivering quality assurance services and allocating quality assurance resources to endure data validity; serve as the USA Health CTO liaison to IRB related Universities committees; complies with state, federal and local legal requirements for clinical research in humans; adheres to legal, professional and ethical codes with respect to confidentiality and privacy; regular and prompt attendance; ability to work schedule as defined and additional hours as required; related duties as required.
Bachelor's degree in a related field from an accredited institution as approved and accepted by the University of South Alabama and five years of directly related experience. Experience working with IRB, FDA Investigational New Drug (IND) applications and industry study monitors is preferred. Experience writing IRB protocols and clinical trials standard operating procedures, and responding to FDA audits is preferred. A master's degree is preferred and may substitute for up to one year of the required experience. EO/AA Employer - minorities/females/veterans/disabilities/sexual orientation/gender identity