"Clinical Research Regulatory Coordinator"

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.

PRIMARY JOB 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

KNOWLEDGE, SKILLS, AND ABILITIES

• 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

MINIMUM QUALIFICATIONS

• Associate's degree
• Five years of related experience, preferably in the field of clinical research
• Three years clinical trials experience with regulatory background

PREFERRED QUALIFICATIONS

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