Clinical Research Regulatory Specialist - SMS-3831

documentation (files, medical records, reports, films, etc) and assists research coordinators and investigators to maintaining research data bases, research source documents and case report forms. May enter patient data into files and automated research databases. May collect, verify records, and maintain data on clinical activity and/or research; prepares associated reports as required. May assist in maintaining patient enrollment folders, consent forms, and supplies. Develops and maintains a positive working relationship within the CCR, outside department, hospital personnel, and outside agencies. May perform miscellaneous job-related duties as assigned. Contact research subjects to coordinate and schedule follow-up visits. Provide follow-up to site monitors, IRB personnel, physicians regarding pertinent patient information when necessary. May be responsible for on call duties including the use of a beeper. Attends mandatory CCR and School of medicine-required meetings, and other work-related educational programs. Gather patients' related information for studies through hospital records; SIU medical records; physician notes and records. May perform periodic internal quality assurance audits of study related materials to maintain site readiness for external audits. May present study information for informed consent and execute informed consent documentation for non-treatment studies. Clinical May perform routine laboratory procedures and patients assessments (i.e., venipuncture). Development/Regulatory Provides IRB regulatory support to residents and faculty, as directed, including but not limited to preparation of IRB submission materials, development of informed consent documents, maintenance of study approvals. Submits protocols and supporting documents to internal and external regulatory bodies (i.e., Institutional Review Board), ensuring trials are consistent with approved proposals to open new studies. Manages and maintains electronic regulatory files (e.g., staff resumes, licenses, training certificates, equipment receipts, investigation logs). Reviews documentation as needed to support regulatory filings, and maintains research files and documentation required by regulations. Updates all databases, and regulatory binders with information pertinent to studying milestone progress, including but not limited to: IRB databases, internal and external spreadsheets, and study electronic systems. Ensures compliance with all applicable local, state, and federal regulations, statutes, and laws, and with agencies including the IRB and Federal Drug Administration (FDA). Maintains compliance with Good Clinical Practice (GCP) guidelines, patient confidentiality (HIPAA) and any other applicable laws. Maintains communication, attends meetings, and answers questions from all involved parties including regulatory bodies (i.e. IRB), pharmaceutical companies (including monitors), principal investigators and colleagues. Works with clinical trial coordinators, research staff and investigators to further communications, helping remove obstacles impeding trial progress. May assist with implementation of new regulatory procedures and/or software in accordance with local, state and federal regulations. May assist with development of new eREG training materials, protocols, and documentation nomenclatures. May assist Regulatory Coordinator in liaison responsibilities between Advarra eREG personnel and CCR eREG development team for best practices for SIU use of eREG. May provide assistance to faculty and staff on the use of eREG. Assist or performs project-specific literature searches and/or literature reviews as the directed by faculty. May assist in preparing and submission of research abstracts and manuscripts for faculty and resident research projects. May assist faculty with the development of materials necessary for regional and/or national presentation of research results. May assist faculty with basic data analysis needs. Will facilitate statistical support needs for projects using institutional and/or department level statisticians, as directed. May assist faculty with submission of internal or external grant applications. Teaching: 5% May assist other research staff, residents, and faculty with preparation and presentation of educational content related to clinical research. May instruct other personnel (i.e., technicians, residents, medical students, nurses, investigators) in protocol requirements and/or research methods as needed. May supervise, with support of project faculty mentors, undergraduate interns and medical students participating in clinical research activities. Administrative Responsibilities: 5% May order supplies and services required for clinical studies in accordance with the budget and Department/University purchasing guidelines. Minimum Qualifications: Graduate of an accredited college with a minimum of a Bachelor's Degree. Sensitive to the needs of underrepresented minority populations. Desired Qualifications: Must have interpersonal skills necessary to maintain cooperative working relationships with CCR employees, physician faculty, and other research staff. Must have basic computer skills and be proficient with software packages including, but not limited to, MS Office (Access, Word, Excel, and PowerPoint). Must have analytical skills necessary in order to gather, organize, and tabulate data. Knowledge of pharmaceutical and medical terminology. Should possess a basic understanding of the policies and the guidelines that govern clinical research activities.