Clinical Research Regulatory Coordinator

Saint Louis University•St. Louis, MO

22h

About The Position

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 SUMMARY The 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.

Requirements

Possess a working knowledge of organizational policies and procedures
Knowledge of industry regulations
High degree of ethical standards
Working knowledge of Medicare/Medical billing processes
Familiarity with Microsoft Office Suite (Excel, PowerPoint, etc.)
Excellent planning, time management and organizational skills
Strong communication and collaborative team building mindset
Strong working knowledge of Food and Drug Administration, Office for Human Research Protections, and International Council for Harmonization regulatory guidelines
Ability to communicate effectively to a broad audience with various needs
Associate's degree
Five years of related experience, preferably in the field of clinical research
Three years clinical trials experience with regulatory background

Nice To Haves

Bachelor's degree
Three years of related experience, preferably in the field of clinical research
ACRP or SOCRA Clinical Research Professional exam completion

Responsibilities

Works 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 teams
Prepare 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-compliance
Reviews current standards and ensures awareness of new and revised standards and assists with development and revision of Policies and Procedures
Utilizes team leading and facilitation skills to support meetings, action plans, development of measures and goals, and data collection
Responsible 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 timely
Provides 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 issues
Applies 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 assigned