Research Regulatory Specialist II

Texas Health Huguley FWS; Orlando (FL); On-site; USD 50,000 - 80,000; Full time

Job summary

Join a forward-thinking organization as a Research Regulatory Specialist II, where you will provide essential regulatory support to the research team. This role involves assisting with FDA applications, managing regulatory processes for multi-site studies, and ensuring compliance with all relevant regulations. You will be part of a community that values professional growth and supports each individual's unique experiences. This position offers a fulfilling opportunity to contribute to impactful research initiatives and enhance your career in a supportive environment.

Benefits

Benefits from Day One

Paid Days Off from Day One

Student Loan Repayment Program

Mental Health Resources and Support

Pet Insurance

Qualifications

• Bachelor’s degree in healthcare or biological sciences with 2 years of clinical research experience.
• 5+ years of healthcare experience including 2 years in clinical research or regulatory affairs.

Responsibilities

• Assist with submission of research protocols to the FDA for IND/IDE applications.
• Coordinate regulatory processes for multi-site studies and ensure compliance.

Skills

Regulatory Compliance

Clinical Research

FDA Submission

Data Compilation

Education

Bachelor’s Degree in Healthcare

Associate Degree in Healthcare

Job description

Job Description - Research Regulatory Specialist II (25016891)

Research Regulatory Specialist II (Job Number: 25016891)

Position Overview

Regulatory Specialist II: AdventHealth Orlando

Benefits and Perks:

• Benefits from Day One
• Paid Days Off from Day One
• Student Loan Repayment Program
• Mental Health Resources and Support
• Pet Insurance*

Our Promise:

Joining AdventHealth means being part of a community that values the wholeness of each person and strives to uplift others in body, mind, and spirit. We support professional growth and spiritual development by extending the Healing Ministry of Christ. We value each individual's unique experiences and believe that together, we are stronger.

Schedule: Full Time

Shift: Days

Community: AdventHealth Orlando

• Located on a lush tropical campus, our flagship hospital has 1,368 beds.
• Serves as a major tertiary facility for the Southeast, Caribbean, and South America.
• Houses one of the largest Emergency Departments and cardiac catheterization labs in the country.
• Provides service to over 32,000 inpatients and 125,000 outpatients annually.

Role Summary

The Research Regulatory Specialist II provides regulatory support to the research team, including tasks from the Research Regulatory Specialist I role. Additional responsibilities include assisting with FDA applications such as IND, IDE, biologics, and coordinating regulatory activities for multi-site research protocols. Acts as a liaison among IRB, FDA, investigators, research teams, sponsors, CROs, and leadership, ensuring compliance and outstanding customer service.

Key Responsibilities

• Assist with submission of research protocols and documents to the FDA for IND/IDE or biologics applications.
• Compile data and documents for regulatory filings.
• Review and prepare reports for FDA submissions.
• Coordinate regulatory processes for multi-site studies.
• Support the orientation of new Regulatory Specialists.
• Prepare and submit research protocols, amendments, and updates, ensuring accuracy and deadlines.
• Manage informed consent documents and revisions, ensuring IRB approval and language accuracy.
• Ensure compliance with all relevant regulations and guidelines.
• Maintain detailed regulatory records and electronic files.
• Coordinate sponsor monitoring visits.
• Disseminate regulatory communications and updates to all stakeholders.
• Follow up on IRB, sponsor, and research team requests promptly.
• Archive and maintain regulatory documents for closed studies.
• Manage research staff credentialing and training documentation.

Qualifications

- Bachelor’s degree in healthcare or biological sciences with at least 2 years of clinical research experience; OR

- Associate Degree with at least 3 years of healthcare or scientific experience, including 2 years in clinical research; OR

- 5+ years of healthcare or scientific experience, including 2 years in clinical research, IRB, or regulatory affairs, with documented regulatory submission experience.

- Certification from professional research organizations (e.g., SOCRA, ACRP, SRA, PRIM&R) is preferred.

Preferred Qualifications

• Experience with FDA and/or NIH audits.
• Experience supporting research in a NCI-designated cancer center.