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
Full Time, Days
You Will Be Responsible For:
The Regulatory Specialist I, provides regulatory support to the research team by handling all of the Institutional Review Board (IRB) and regulatory submissions and maintenance for AdventHealth Research Institute (AHRI) research activities. The Research Regulatory Specialist I, coordinates the research protocol start-up phase, submission, maintenance and close-out phases throughout the life of the study, ensuring it is done in compliance with all applicable Federal regulations, institutional policies, and other requirements. The Research Regulatory Specialist I, functions as a liaison between the IRB of record for each study protocol and the investigator, the study team, 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.
What You Will Need:
EDUCATION AND EXPERIENCE REQUIRED:
Associate degree in healthcare related field or biological sciences; OR
Equivalent work consisting of at least two years of experience in healthcare, clinical research or scientific setting, an institutional review board office, or related field.
EDUCATION AND EXPERIENCE PREFERRED:
Bachelor’s degree in healthcare, administration, or research related field.
Minimum one year of experience working in a clinical research environment including a stand-alone research site, a research department, or in research administration such as a centralized research office, or with an institutional review board office.
Experience in submitting and maintaining regulatory documents, including research essential regulatory documents, conflicts of interest, financial conflicts of interest, and/or ClinicalTrials.gov.
LICENSURE, CERTIFICATION OR REGISTRATION PREFERRED:
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).
KNOWLEDGE AND SKILLS REQUIRED:
Awareness of and ability to interpret U.S. Code of Federal Regulations (CFR) related to the conduct of research including The Common Rule, Food and Drug Administration (FDA) regulations and the International Conference on Harmonization/Good Clinical Practice (ICH/GCP) guidelines.
Ability to troubleshoot and appropriately report unexpected problems that may arise during the conduct of clinical trials.
Computer skills including Microsoft Office applications and Adobe.
Strong verbal and written communication skills including ability to interact with varied professionals.
Good time management skills and the ability to work independently with attention to detail.
Good organizational skills, electronic filing skills, and ability to multi-task performing under aggressive regulatory and/or internal deadlines.
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.
KNOWLEDGE AND SKILLS PREFERRED:
Working knowledge of the U.S. Code of Federal Regulations (CFR) related to the conduct of research including The Common Rule, FDA regulations governing research with investigational drugs, devices, and biologics, and the International Conference on Harmonization/Good Clinical Practice (ICH/GCP) guidelines.
Working knowledge of a broader range of federal regulatory requirements including, but not limited to, Office of Human Research Protection (OHRP), 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 of electronic management systems for research, especially IRBNet, Florence eRegulatory application, and/or Clinical Conductor clinical trials management system (CTMS).
Knowledge of the research regulatory submission process.
Knowledge of the AdventHealth Research Institute (AHRI) Institutional Review Board (IRB) policies, procedures, and processes.
Working knowledge of medical terminology.
PRINCIPAL DUTIES AND JOB RESPONSIBILITIES:
Responsible for preparing and submitting new research protocols, protocol amendments, continuing reviews, 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.
Maintains regulatory documents by creating electronic folders in the eRegulatory application, filing them electronically, following standard file name criteria and keeping all documents current, per the AdventHealth Orlando SOP 403.002- Florence eRegulatory Essential Document Maintenance, and all Federal, State, and IRB requirements.
Assist in the coordination of sponsor monitoring visits ensuring proper access to eRegulatory files.
Ensures the effective dissemination of all regulatory communications and study updates to investigators, study teams, clinical department managers and senior managers, data managers, the IRB, and all other appropriate research staff to facilitate protocol adherence, patient safety, and regulatory compliance.
Provides timely follow up on requests from IRB, sponsors, study teams, research leadership and administration in a courteous and professional manner.
Ensures regulatory documents for all closed studies are archived and maintained per the applicable regulatory retention period, sponsor requirements, State, IRB, and AHRI policies and procedures.
Facilitates proper and timely research credentialing of all research staff and study team members by maintaining the Research Personnel Log ensuring it is accurate and updated in a timely manner. Also maintaining curriculum vitae’s (CVs), licenses and/or certifications, and documentation of completion of all AHRI and Sponsor mandatory training.
Communicate with COI office confirming if there are any COI Management Plans (MPs) related to each research protocol notifying the study team of all MPs to be implemented.
Confirms with study Sponsor and/or study team if the research protocol is required to be registered on ClinicalTrials.gov, and if required, ensure it is accomplished within the required time period.
Supports internal and external auditing and monitoring needs, assisting auditors and making requested documents available for review.
Performs other duties and/or special projects as assigned by Research Regulatory Manager or Director, Office of Research Integrity.
At AdventHealth, Extending the Healing Ministry of Christ is our mission. It calls us to be His hands and feet in helping people feel whole. Our story is one of hope — one that strives to heal and restore the body, mind and spirit. Our more than 80,000 skilled and compassionate caregivers in hospitals, physician practices, outpatient clinics, urgent care centers, skilled nursing facilities, home health agencies and hospice centers are committed to providing individualized, wholistic care.