Research Regulatory Specialist Iii

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

• Benefits from Day One
• Paid Days Off from Day One

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. Where you will be valued for who you are and the unique experiences you bring to our purpose-minded team. All while understanding that together we are even better.

Schedule: Full Time/Days (M-F)

Location: Fully Remote

The community you’ll be caring for:

• 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
• AdventHealth Orlando houses one of the largest Emergency Departments and largest cardiac catheterization labs in the country
• We are already one of the busiest hospitals in the nation, providing service excellence to more than 32,000 inpatients and 125,000 outpatients each year.

The role you’ll contribute:

The Research Regulatory Specialist III, provides regulatory support to the research team by conducting all the tasks and activities of the Research Regulatory Specialist I, and has the additional responsibilities of supporting AdventHealth Research Institute (AHRI) research investigators with investigational new drug (IND), investigational device exemption (IDE), and/or biologics applications to the FDA. The Research Regulatory Specialist III supports AHRI investigators and study teams by coordinating the regulatory activities for AHRI led multi-site research protocols and ensuring effective communication between AHRI as the coordinating center and the participating sites. The Research Regulatory Specialist III functions as a liaison between the IRB of record for each study protocol, the Food and Drug Administration (FDA), and the investigator, the AHRI study team, other study teams participating in AHRI led multi-site studies, the Sponsor, Contract Research Organization (CRO), Office of Sponsored Programs (OSP), the research Conflicts of Interest (COI) office, the clinical research department Managers and Sr. Managers, and AHRI Leadership. Actively participates in outstanding customer service and accepts responsibility in maintaining relationships that are equally respectful to all.

2/28/22

The value you’ll bring to the team:

• Responsible for submission of research protocols and other required documents/components to the FDA for AdventHealth held investigational new drug (IND)/investigational device exemption (IDE) or biologics applications.
• Provides data and document collection and compilation for regulatory filing with the FDA and other regulatory authorities.
• Provides technical review and report preparation and submission of FDA required reports of ongoing AdventHealth sponsored and held IND/IDE applications.
• Coordinates regulatory processes and submissions for AdventHealth led multi-site research.
• Assists Research Regulatory Manager in the orientation of new Research Regulatory Specialists.

Qualifications

The expertise and experiences you’ll need to succeed:

KNOWLEDGE AND SKILLS REQUIRED:

• Subject matter expert in U.S. Code of Federal Regulations (CFR) related to the conduct of research including The Common Rule, FDA regulations governing research including investigational drugs, devices, and biologics, and the International Conference on Harmonization/Good Clinical Practice (ICH/GCP) guidelines, the National Institutes of Health (NIH), the Public Health Service (PHS) regulations for maintaining objectivity in research related to financial conflicts of interest, and PHS regulations related to research misconduct, and Federal regulations related to ClinicalTrials.gov registration and reporting.
• Proficient in the Research Regulatory submission process.
• Ability to troubleshoot and appropriately report unexpected problems that may arise during the conduct of clinical trials.
• Working knowledge of medical terminology.
• Ability to maintain strict confidentiality of employees, other research team members, patients, research subjects, and institution AdventHealth information, especially related to patient protected health information and disclosed financial information and interests.

EDUCATION AND EXPERIENCE REQUIRED:

• Bachelor’s degree in healthcare related field or biological sciences; and at least four (4) years applicable work experience in the Research Regulatory field (working in a clinical research or scientific setting including FDA and/or NIH audits) OR
• Associate Degree and at least six (6) years applicable work experience in the Research Regulatory field (working in a clinical research or scientific setting – including FDA and/or NIH audits); OR
• Equivalent work consisting of at least eight (8) years of experience working in the Research Regulatory field in a clinical research or scientific setting, an institutional review board office, research administration, or regulatory affairs in a pharmaceutical and/or medical device company.
• Work experience includes documented experience in submitting and maintaining regulatory documents including research essential regulatory documents, conflicts of interest, financial conflicts of interest, and/or ClinicalTrials.gov or FDA and/or NIH audits.

LICENSURE, CERTIFICATION OR REGISTRATION REQUIRED:

• Certification through any professional research organization such as the Society of Clinical Research Associates (SOCRA), Association of Clinical Research Professionals (ACRP), Society of Research Administrators International (SRA), or Public Responsibility in Medicine & Research (PRIM&R).

This facility is an equal opportunity employer and complies with federal, state and local anti-discrimination laws, regulations and ordinances. The salary range reflects the anticipated base pay range for this position. Individual compensation is determined based on skills, experience and other relevant factors within this pay range. The minimums and maximums for each position may vary based on geographical location.

Category: Research

Organization: AdventHealth Orlando

Schedule: Full-time

Shift: 1 - Day

Req ID: 24008861

We are an equal opportunity employer and do not tolerate discrimination based on race, color, creed, religion, national origin, sex, marital status, age or disability/handicap with respect to recruitment, selection, placement, promotion, wages, benefits and other terms and conditions of employment.