Location: all cities,FL, USA
All the benefits and perks you need for you and your family:
* Paid Parental Leave
* Pet Insurance
* Benefits from Day One
* Student Loan Repayment Program & Debt-free Education
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 Exempt Salaried
Shift : Days
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.
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.
* Responsible for preparing and submitting new research protocols, protocol amendments, continuing reviews, other study modifications, investigational product updates (investigational brochures and/or device manuals) and ensuring completeness and accuracy of documents while meeting all applicable submission deadlines.
* Responsible for preparing and submitting new informed consent documents, revisions to the informed consent, including any required financial disclosure language, and communicating when IRB requires re-consenting of enrolled subjects. Also ensuring all languages of the informed consent requested by the study team are reviewed and approved.
Qualifications
The expertise and experiences you'll need to succeed:
* 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.
* Working knowledge of medical terminology.
* 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.
* 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: 24033008
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.