Address
Form of workAll 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
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 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.
The expertise and experiences you'll need to succeed: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.
EDUCATION AND EXPERIENCE PREFERRED:
Experience in providing Research Regulatory support in a National Cancer Institute (NCI) designated cancer center.
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)
