Job Title

Who is Saint Louis University? Founded in 1818, Saint Louis University is one of the nation's oldest and most prestigious Catholic universities. SLU, which also has a campus in Madrid, Spain, is recognized for world-class academics, life-changing research, compassionate health care, and a strong commitment to faith and service.JOB SUMMARYThe Clinical Research Regulatory Coordinator promotes and facilitates the regulatory compliance for the division; independently completing a multitude of regulatory responsibilities. The position is responsible for submitting reports, amendments, and continuing review to the IRB; processing approved documents; creating essential study documents for regulatory files and outside sponsors; and creating and auditing all study regulatory documents. The position upholds compliance by developing and exercising procedures to ensure timely document flow (paper and electronic) between the regulatory library, IRB, and outside sponsors.PRIMARY JOB RESPONSIBILITIESWorks collaboratively with leaders, clinicians and other staff in the development and implementation of regulatory requirements to identify and reduce risks and meet regulatory and accreditation requirements. Conducts investigations and audits to identify areas of risk; communicates regulatory findings to administrative teamsPrepare and record data generated for clinical trials and ensure compliance with regulations. Works with leaders to develop, implement and monitor action plans for any identified non-complianceReviews current standards and ensures awareness of new and revised standards and assists with development and revision of Policies and ProceduresUtilizes team leading and facilitation skills to support meetings, action plans, development of measures and goals, and data collectionResponsible for developing and monitoring action plans to address compliance issues. Drafts plans for improving compliance practices to address those risks and monitors to ensure the program is following best practices and standards and that all required regulatory related reports within the department/division are completed and submitted to regulatory agencies accurately and timelyProvides education, consultation and interpretation of regulations and accreditation standards according to university policies and gathers data from tracers and chart audits to create scorecards related to key compliance issuesApplies rigorous attention to detail in auditing and maintaining regulatory records, identifying even minor discrepancies to ensure accuracy, completeness, and consistency across IRB submissions, sponsor communications, and internal regulatory files.Performs other duties as assignedKNOWLEDGE, SKILLS, AND ABILITIESPossess a working knowledge of organizational policies and proceduresKnowledge of industry regulationsHigh degree of ethical standardsWorking knowledge of Medicare/Medical billing processesFamiliarity with Microsoft Office Suite (Excel, PowerPoint, etc.)Excellent planning, time management and organizational skillsStrong communication and collaborative team building mindsetStrong working knowledge of Food and Drug Administration, Office for Human Research Protections, and International Council for Harmonization regulatory guidelinesAbility to communicate effectively to a broad audience with various needsMINIMUM QUALIFICATIONSAssociate's degreeFive years of related experience, preferably in the field of clinical researchThree years clinical trials experience with regulatory backgroundPREFERRED QUALIFICATIONSBachelor's degreeThree years of related experience, preferably in the field of clinical researchACRP or SOCRA Clinical Research Professional exam completionFunctionClinical ResearchScheduled Weekly Hours:40Saint Louis University is an equal opportunity/affirmative action employer. All qualified candidates will receive consideration for the position applied for without regard to race, color, religion, sex, age, national origin, disability, marital status, sexual orientation, military/veteran status, gender identity, or other non-merit factors. If accommodations are needed for completing the application and/or with the interviewing process, please contact Human Resources at 314-977-5847.