What are the responsibilities and job description for the Clinical Research Regulatory Specialist position at University of South Alabama Health System?
Overview
USA Health is Transforming Medicine along the Gulf Coast to care for the unique needs of our community. USA Health is changing how medical care, education and research impact the health of people who live in Mobile and the surrounding area. Our team of doctors, advanced care providers, nurses, therapists and researchers provide the region's most advanced medicine at multiple facilities, campuses, clinics and classrooms. We offer patients convenient access to innovative treatments and advancements that improve the health and overall wellbeing of our community.
Responsibilities
Responsible for regulatory activities, submission and compliance of human subject clinical trial regulatory related activities for the University of South Alabama Health Clinical Trial Office (USA Health CTO); works with research sponsors, University of South Alabama Institutional Review Board and external regulatory agencies to ensure consent language meets university standards and federal regulations; works with the USA Health 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 lo internal IRB, external IRB and trial sponsor; reviews safely reports for each trial and communicates to Principal Investigator and other pertinent individuals in a timely manner; assists with the resolution of data queries when needed; maintain weekly/monthly IRB status report; communicates this information at the weekly CTO clinical trial start up meetings and at the monthly Clinical Research Committee; assists in the development and Implementation of new protocols related to regulatory and compliance topics In research; ensures that all principals of good clinical practices (GCP) in clinical trials and all other required education and/or training of staff and physicians are up lo date before the opening of each trial; actively participates in site evaluation visits, site initiation visits, and closeout visits; assists in facilitating both remote and onsite monitor visits; works with clinical applications team to ensure all trails are entered and maintained In the electronic medical record for new trials and trial amendments; implements and maintains standardized process for review of regulatory binders, binder maintenance and/or electronic access for external review; implements and maintains standardized format for the setup, filing and long term storage of regulatory binders and documents; 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; assists in standardizing procedures for the quality assurance of all study databases; ensures compliance 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.
Qualifications
Bachelor’s degree in a related field from an accredited institution as approved and accepted by the University of South Alabama and two years of directly related experience. Regulatory experience in healthcare research is preferred and will substitute on a year-for-year basis for the required education.
