Role Description The Research Regulatory Coordinator is responsible for collaborating with the PI’s and internal and external members of the clinical research team within the scope of clinical trial regulatory submission and compliance. Key responsibilities include:

• Assisting in preparing regulatory submissions and maintaining regulatory files.
• Coordinating the preparation of regulatory documents for submission to the Institutional Review Board (IRB) or other IRBs, internal committees, and the FDA.
• Maintaining master regulatory files in accordance with institutional, state, and federal regulations.
• Demonstrating working knowledge of all facets of the role, relevant regulations, and organizational policies and procedures.
• Performing other duties and projects as assigned in accordance with regulatory requirements and organizational policies.

Qualifications

• High school education required.
• Bachelor’s degree in Biological Science, Social Sciences, English, or other related field preferred.
• Valid state Driver’s License for travel to satellite offices and offsite meetings.
• Prior clinical research experience is preferred but not required.

Requirements

• Critical thinking skills including solid problem solving, analysis, decision-making, planning, time management, and organizational skills.
• Developed interpersonal skills, emotional intelligence, diplomacy, tact, conflict management, and delegation skills.
• Good command of the English language; second language is an asset but not required.
• Strong customer focus and ability to build an engaging culture of quality and performance effectiveness.
• Effectively manages own time, conflicting priorities, self, stress, and professional development.
• Proficiency in MS Office Word, Excel, PowerPoint, and Outlook expected.

Benefits

• Standard Core Workdays/Hours: Monday to Friday 8:00 AM – 5:00 PM.
• Travel: 0%