Regulatory Specialist I – AdventHealth Orlando

All the benefits and perks you need for you and your family:

Benefits from Day One

Paid Days Off from Day One

Student Loan Repayment Program

Career Development

Whole Person Wellbeing Resources

Mental Health Resources and Support

Pet Insurance*

Debt-free Education* (Certifications and Degrees without out-of-pocket tuition expense)

Nursing Clinical Ladder Program*

Sign-on Bonus*

Relocation Bonus*

- Team Based Nursing Model*

* Nursing or BU specific benefits and perks

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.

Schedule: Full Time,

Shift : Monday-Friday 8-5, Hybrid

Location: 800 N. Magnolia Avenue, Suite 500, Orlando 32803

The community you’ll be caring for: 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

The role you’ll contribute:

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.

The value you’ll bring to the team: 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.

Minimum qualifications

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.

Preferred qualifications:

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.

o 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).

This facility is an equal opportunity employer and complies with federal, state and local anti-discrimination laws, regulations and ordinances. The salary range reflects the anticipated base pay range for this position. Individual compensation is determined based on skills, experience and other relevant factors within this pay range. The minimums and maximums for each position may vary based on geographical location.

Category: Research

Organization: AdventHealth Orlando

Schedule: Full-time

Shift: 1 - Day

Req ID: 24039627

We are an equal opportunity employer and do not tolerate discrimination based on race, color, creed, religion, national origin, sex, marital status, age or disability/handicap with respect to recruitment, selection, placement, promotion, wages, benefits and other terms and conditions of employment.