Research Regulatory Specialist Ii

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.
Shift : Monday - Friday Day shift
The community you'll be caring for:
• Located on a lush tropical campus, our flagship hospital, 1,368-bed AdventHealth Orlando
• We offer great benefits with immediate Health Insurance coverage
• Career growth and advancement potential
• 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 II, 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 assisting the Research Regulatory Specialist III to support AdventHealth Research Institute (AHRI) research investigators with investigational new drug (IND), investigational device exemption (IDE), and/or biologics applications to the FDA; and coordination of the regulatory activities for AHRI led multi-site research protocols. The Research Regulatory Specialist II 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 assisting with the 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.
• Assists with the 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.
• Ensure all regulatory documents, including all Essential Documents as defined by the ICH/GCP guidelines, are in compliance with all applicable Federal regulations, ICH/GCP guidelines, as well as the Association for the Accreditation of Human Research Protection Programs (AAHRPP) standards and all applicable AHRI policies and procedures.
• Monitors all required review, approval, and clearance activities for each research protocol maintaining detailed, complete, accurate and current records at the various stages of the process.

Qualifications
The expertise and experiences you'll need to succeed:
KNOWLEDGE AND SKILLS REQUIRED:
• Working knowledge of and ability to interpret 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.
KNOWLEDGE AND SKILLS PREFERRED:

• Proficient in electronic management systems for research, especially IRBNet, Florence eRegulatory application, and/or Clinical Conductor clinical trials management system (CTMS).
• Expertise in AdventHealth Research Institute (AHRI) Institutional Review Board (IRB) policies, procedures, and processes.

EDUCATION AND EXPERIENCE REQUIRED:

• Bachelor's degree in healthcare related field or biological sciences and at least 2 years work experience in a clinical research setting; OR
• Associate Degree and at least 3 years work experience in a healthcare or scientific setting, with at least 2 years in a clinical research setting; OR
• Equivalent work consisting of at least five (5) years of experience working in a healthcare or scientific setting, with at least 2 years in a clinical research setting including 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.
• EDUCATION AND EXPERIENCE PREFERRED:
  • Experience with FDA and/or NIH audits.
  • 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) or certificate with research related course work included deemed satisfactory and applicable by hiring manager.