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Regulatory Specialist ( II AND III) at AdventHealth Orlando

Location Address: AdventHealth Orlando

Top Reasons to work at AdventHealth Orlando:

• 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

Work Hours/Shift: Full Time Days

You Will Be Responsible For:

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.

· 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.

· 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.

· 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.

What You Will Need:

KNOWLEDGE AND SKILLS REQUIRED:

• Proficient in MS Office applications and Adobe.
• (Awareness to Subject matter expert) 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.
• Knowledge of the research regulatory submission process.
• Ability to troubleshoot and appropriately report unexpected problems that may arise during the conduct of clinical trials.
• Excellent 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.

EDUCATION AND EXPERIENCE REQUIRED FOR LEVEL II

• 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.

CERTIFICATION REQUIRED FOR LEVEL II

• 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)

EDUCATION AND EXPERIENCE REQUIRED FOR LEVEL III:

• 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 REQUIRED FOR LEVEL III:

• 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)

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About AdventHealth

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.

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