CLINICAL RESEARCH REGULATORY COORDINATOR I (3)

General Responsibilities

• To assist in maintaining regulatory documentation including consent forms, protocols, 1572s, CVs, licenses, investigator brochures, recruitment materials, safety reports, and submission forms.
• To assist with preparation of Institutional Review Board (IRB) submissions, including preparing all relevant documentation and obtaining necessary signatures to meet study timelines.
• To assist with initial drafts of informed consent documents.
• To prepare regulatory binders and associated documentation.

Key Duties & Responsibilities

• Maintains regulatory documentation including consent forms, protocols, 1572s, CVs, licenses, investigator brochures, recruitment materials, safety reports, and submission forms.
• Assists with preparation of Institutional Review Board (IRB) submissions, including preparing all relevant documentation and obtaining necessary signatures to meet study timelines.
• Assists with initial drafts of informed consent documents.
• Prepares regulatory binders and associated documentation.
• Enters protocol specific data into required institutional systems (IRAP and OnCore).
• Maintains Delegation of Authority logs.
• Performs other duties as assigned.

Qualifications

HIGH SCHOOL DIPLOMA OR GED REQUIRED.

PREFERRED HARD SKILLS:

• Clinical research, healthcare, or regulatory experience preferred.
• Familiarity with IRB processes or regulatory documentation is a plus.
• Strong computer skills, including Microsoft Office.

Soft Skills

• Strong attention to detail and organizational skills.
• Excellent written and verbal communication.
• Ability to manage multiple priorities and regulatory submission deadlines.
• Collaborative and proactive.
• Willingness to learn and grow in a fast-paced regulatory environment.

Pay

HOURLY RANGE: $18.85 - $30.65

Schedule

Day/1st Shift

Remote/Hybrid Eligibility

Remote/Hybrid Eligible