Research Regulatory Specialist II

AdventHealth; Orlando (FL); On-site; USD 50,000 - 80,000; Full time

Job summary

An established industry player is seeking a Regulatory Specialist II to provide essential regulatory support to their research team. This role is pivotal in coordinating regulatory activities for multi-site research protocols and acting as a liaison among various stakeholders, including IRBs and the FDA. The ideal candidate will thrive in a collaborative environment, ensuring compliance with regulatory standards and delivering outstanding service. Join a community that values your unique experiences and contributes to uplifting others in body, mind, and spirit while advancing your professional growth.

Benefits

Benefits from Day One

Paid Days Off from Day One

Student Loan Repayment Program

Career Development

Whole Person Wellbeing Resources

Mental Health Resources and Support

Pet Insurance

Qualifications

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

Responsibilities

• Assist with submission of research protocols and documents to the FDA.
• Coordinate regulatory processes for multi-site research.
• Ensure compliance of regulatory documents with federal and state standards.

Skills

Regulatory Submissions

Clinical Research

FDA Regulations

IRB Coordination

Data Compilation

Education

Bachelor's Degree in Healthcare or Biological Sciences

Associate Degree

Certification from SOCRA, ACRP, SRA, or PRIM&R

Job description

Regulatory Specialist II: AdventHealth Orlando

All the benefits and perks you need for you and your family:

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

Our promise to you:

Joining AdventHealth is about being part of something bigger. It’s about belonging to a community that believes in the wholeness of each person, and serves to uplift others in body, mind and spirit. AdventHealth is a place where you can thrive professionally, and grow spiritually, by extending the healing ministry of Christ. You will be valued for who you are and the unique experiences you bring to our purpose-minded team, understanding that together we are even better.

Schedule: Full Time

Shift: Days

Location: 800 N MAGNOLIA AVE, Orlando, 32803

The community you’ll be caring for: AdventHealth Orlando

• Located on a lush tropical campus, our flagship hospital, 1,368-bed AdventHealth Orlando
• Serves as the major tertiary facility for much of the Southeast, the 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

The role you’ll contribute:

The Research Regulatory Specialist II provides regulatory support to the research team by performing all tasks of the Research Regulatory Specialist I, and additionally assists the Research Regulatory Specialist III in supporting research investigators with FDA applications such as IND, IDE, and biologics. This role involves coordinating regulatory activities for multi-site research protocols, acting as a liaison among IRBs, FDA, investigators, research teams, sponsors, CROs, and other stakeholders. The specialist actively participates in delivering outstanding customer service and maintains respectful relationships with all parties.

• The value you’ll bring to the team:
• Assist with submission of research protocols and documents to the FDA for IND/IDE or biologics applications.
• Compile data and documents for regulatory filings with FDA and other agencies.
• Review and prepare reports for FDA submissions of ongoing IND/IDE applications.
• Coordinate regulatory processes for multi-site research.
• Support the onboarding of new Regulatory Specialists.
• Prepare and submit new research protocols, amendments, reviews, and study modifications, ensuring accuracy and timely submission.
• Manage informed consent documents, including revisions and re-consenting procedures.
• Ensure compliance of regulatory documents with ICH/GCP, AAHRPP, federal, state, and institutional standards.
• Monitor review, approval, and clearance activities, maintaining detailed records.
• Maintain regulatory documents electronically, following SOPs and legal requirements.
• Coordinate sponsor monitoring visits and facilitate communication among stakeholders.
• Archive documents of closed studies per retention policies.
• Maintain research personnel logs, CVs, licenses, certifications, and training records.

• Minimum qualifications:

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

- Associate Degree + 3 years of healthcare/scientific experience, with 2 years in clinical research; OR

- 5 years of healthcare/scientific experience with 2 years in clinical research, IRB, or regulatory affairs, including experience with regulatory submissions.

- Certification from organizations like SOCRA, ACRP, SRA, or PRIM&R, or relevant coursework deemed satisfactory by the hiring manager.

• Preferred qualifications:
• Experience with FDA and/or NIH audits.
• Experience supporting research in an NCI-designated cancer center.