Research Regulatory Specialist II

** Our promise to you:*
* Joining Advent Health 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. Advent Health 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.

** All the benefits and perks you need for you and your family:*
* + Benefits from Day One:
Medical, Dental, Vision Insurance, Life Insurance, Disability Insurance

+ Paid Time Off from Day One

+ 403-B Retirement Plan

+ 4 Weeks 100% Paid Parental Leave

+ Career Development

+ Whole Person Well-being Resources

+ Mental Health Resources and Support

+ Pet Benefits

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* Schedule:

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* Full time

** Shift:*
* Day (United States of America)

** Address:*
* 800 N Magnolia Ave

** City:*
* Orlando

** State:*
* Florida

** Postal Code:*
* 32803

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* Job Description:

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* 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 Advent Health 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 Advent Health 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.

Clinical Trials.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 Advent Health 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…