Research Regulatory Specialist II

Day (United States of America)

800 N Magnolia Ave

Orlando

Florida

32803

Other duties as assigned. 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. Maintain the Research personnel log (e.g. DOAs) and ensure they are accurate and updated in a timely manner. Also maintaining Protocol and Sponsor mandatory training documentation. 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. Ensuring timely updates of study status in systems such as the Electronic Medical Record (EMR) and Clinical Trial Management System (CTMS). 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. 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. Assists with the technical review and report preparation and submission of FDA required reports of ongoing AdventHealth sponsored and held IND/IDE applications. 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, 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. May confirm with study Sponsor and/or study team if the research protocol is required to be registered on www.ClinicalTrials.gov, and if required, may 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. 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. 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. 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.Knowledge, Skills, and Abilities:
• 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. [Required]
• Knowledge of the research regulatory submission process. [Required]
• Ability to troubleshoot and appropriately report unexpected problems that may arise during the conduct of clinical trials. [Required]
• Working knowledge of medical terminology. [Required]
• Proficient in Microsoft Office applications, Adobe, and internet skills. [Required]
• Strong verbal and written communication skills including ability to interact with varied professionals. [Required]
• Strong time management skills and the ability to work independently with attention to detail. [Required]
• Excellent organizational skills, electronic filing skills, and ability to multi-task performing under aggressive regulatory and/or internal deadlines. [Required]
• 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. [Required]
• Proficient in electronic management systems for research, especially IRBNet, Florence eRegulatory application, and/or Clinical Conductor clinical trials management system (CTMS). [Preferred]
• Expertise in AdventHealth Research Institute (AHRI) Institutional Review Board (IRB) policies, procedures, and processes. [Preferred]

Education:
• Associate [Preferred]
• Bachelor's in healthcare related field or biological sciences [Preferred]

Field of Study:
• Degree healthcare related field or biological sciences and at least 3 years' work experience in clinical research setting
• degree and at least 4 years' work experience in a healthcare or scientific setting, with at least 2 years in clinical research setting

Work Experience:
• 5+ 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. [Required]
• Experience in providing research regulatory support in a National Cancer Institute (NCI) designated cancer center. [Preferred]
• Experience with FDA and/or NIH audits. [Preferred]

Additional Information:
• N/A

Licenses and Certifications:
• N/A

Physical Requirements: (Please click the link below to view work requirements)
Physical Requirements - https://tinyurl.com/23km2677

$49,795.20 - $92,622.40