Clinical Research Regulatory Specialist II

adventhealth; Orlando (FL); On-site; USD 50,000 - 93,000; Full time

Benefits offered by this job

Medical, Dental, Vision Insurance

Paid Time Off

403-B Retirement Plan

Parental Leave

Career Development

Well-being Resources

Mental Health Resources

Pet Benefits

Job summary

AdventHealth Orlando is seeking a Research Regulatory Specialist to manage essential regulatory documents, submit to the FDA, and coordinate IRB activities. You will maintain eRegulatory records, ensure compliance with ICH/GCP, CFR, AHRI policies, and prepare reports for audits and sponsor communications.

Experience in regulatory affairs within clinical research and familiarity with IRBNet, Florence eRegulatory, and CTMS is preferred.

Qualifications

• Knowledge of CFR, The Common Rule, FDA regulations for research.
• Experience with regulatory submissions in clinical trials.
• Ability to ensure regulatory documentation accuracy and timeliness.

Responsibilities

• Maintain regulatory documents and eRegulatory folders.
• Assist with FDA submissions for IND/IDE/biologics when required.
• Coordinate sponsor monitoring visits and audits.

Skills

Regulatory knowledge

FDA/ICH/GCP

Documentation

Attention to detail

Microsoft Office

Communication skills

Education

Associate

Bachelor's in healthcare or biological sciences

Tools

IRBNet

Florence eRegulatory

Clinical Conductor CTMS

Job description

AdventHealth Orlando is seeking a Research Regulatory Specialist to manage essential regulatory documents, submit to the FDA, and coordinate IRB activities. You will maintain eRegulatory records, ensure compliance with ICH/GCP, CFR, AHRI policies, and prepare reports for audits and sponsor communications.

Experience in regulatory affairs within clinical research and familiarity with IRBNet, Florence eRegulatory, and CTMS is preferred.