Position Summary

The Clinical Research Regulatory Coordinator II will prepare, submit, and assist with multiple levels of clinical research documentation (i.e., IRB submissions, educational materials, reports, grant renewal reports, and study forms) for the Rheumatology Research Unit. The coordinator will maintain regulatory documentation, including consent forms, protocols, CVs, licenses, investigator brochures, recruitment materials, safety reports, and submission forms. The coordinator will serve as a resource person or act as a consultant within the area of regulatory expertise.

General Responsibilities

• To prepare, submit, and assist with multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms).
• To maintain regulatory documentation including consent forms, protocols, 1572s, CVs, licenses, investigator brochures, recruitment materials, safety reports, and submission forms.
• To draft informed consents.
• To prepare and maintain FDA applications for Investigational New Drugs (INDs) and Investigational Device Exemptions (IDEs).
• To assist in drafting compliant advertisements.
• To serve as resource person or act as consultant within area of regulatory expertise

Primary Responsibilities

• Regulatory Experience/IRB
• Prepares and submits IRB applications for the Division of Rheumatology.
• Assists in drafting IRB-compliant consents, advertisements, and correspondence.
• Makes and assists in modifying protocols and study documents.
• Completes and submits safety Reports and government documents as needed.
• Enters protocol-specific data into required institutional systems (IRAP, OnCore).
• Maintains pertinent records and personnel documentation (e.g., licensure, certifications) for research staff.
• Maintain IRB compliance with institutional and departmental requirements for various Division of Rheumatology studies.
• Assists colleagues in identifying efficiencies and improving processes.
• Performs other duties as assigned.

Annual Salary Range - $47,665 - $77,455

Qualifications

Bachelor's degree in a related field and three (3) years of related experience required. Work experience may substitute for education requirement.

Preferred Qualifications

• Comprehensive understanding of related scientific and clinical terminology
• Organizational skills
• Interpersonal skills
• Ability to problem-solve
• Clinical Research experience
• Knowledge of regulatory/compliance affairs as it pertains to clinical research