Research Regulatory Specialist Supervisor - AdventHealth
Orlando, FL
About the Job
Research Regulatory Specialist Supervisor – 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, Days_ - Monday - Friday
Shift : _8:00am – 5:00pm_
Location: Remote
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 Research Regulatory Specialist Supervisor provides regulatory support and supervision to the research team by conducting all the tasks and activities of the Research Regulatory Specialist and has the additional responsibilities of supervising, and training, the Research Regulatory Specialist team (I-III). The Research Regulatory Specialist Supervisor oversees the day-to-day work activities of the Regulatory Specialists, and works with the Manager, Research Regulatory Services to orients staff new to the regulatory team. The Research Regulatory Specialist Supervisor works closely with the Research Regulatory Manager to identify training and mentoring needs of the regulatory team including specific processes, SOPs, Work Instructions, team members, etc. The Research Regulatory Specialist Supervisor supports AHRI investigators and study teams by coordinating the regulatory activities for AHRI led multi-site research protocols and ensuring effective communication between AHRI as the coordinating center and the participating sites. 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:
• • Performs a variety of supervisory duties related to the management, performance, evaluations, development conversations, timekeeping, and workflow of the Regulatory Specialists team.
• Supervise the work assignments, priorities, and productivity, including the development of training processes and materials of the Regulatory Specialists team.
• Serves as a preceptor for all new study coordinators, including the development of training processes and material.
• Provides guidance and mentorship to promote growth for study team members, including those in new positions.
• Responsible for submissions 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, as applicable.
• Provides data and document collection and compilation for regulatory filing with the FDA and other regulatory authorities.
• May provide technical review and report preparation and submission of FDA required reports of ongoing AdventHealth sponsored and held IND/IDE applications.
• Coordinates regulatory processes and submissions for AdventHealth led multi-site research.
The expertise and experiences you’ll need to succeed :
+ Minimum qualifications :
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)
+ Work experience includes documented experience in submitting and maintaining research essential regulatory documents, working with Central Institutional Review Boards, financial conflicts of interest, and/or ClinicalTrials.gov, and experience with FDA and/or NIH audits; AND
+ Bachelor’s degree in healthcare related field or biological sciences; and at least five (5) years applicable work experience in the research regulatory field (working in a clinical research or scientific setting; OR
+ Associate Degree and at least seven (7) years applicable work experience in the research regulatory field (working in a clinical research or scientific setting)
+ Experience in management and/or teaching or training of employees.
+ Preferred qualifications:
o Experience in providing research regulatory support in a National Cancer Institute (NCI) designated cancer center.
o Master’s degree in healthcare related field or biological sciences
o Experience submitting IND/IDE applications to the FDA and/or supporting research investigators functioning in a Sponsor-Investigator role who hold an IDE or IND.
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: 24036583
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.
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, Days_ - Monday - Friday
Shift : _8:00am – 5:00pm_
Location: Remote
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 Research Regulatory Specialist Supervisor provides regulatory support and supervision to the research team by conducting all the tasks and activities of the Research Regulatory Specialist and has the additional responsibilities of supervising, and training, the Research Regulatory Specialist team (I-III). The Research Regulatory Specialist Supervisor oversees the day-to-day work activities of the Regulatory Specialists, and works with the Manager, Research Regulatory Services to orients staff new to the regulatory team. The Research Regulatory Specialist Supervisor works closely with the Research Regulatory Manager to identify training and mentoring needs of the regulatory team including specific processes, SOPs, Work Instructions, team members, etc. The Research Regulatory Specialist Supervisor supports AHRI investigators and study teams by coordinating the regulatory activities for AHRI led multi-site research protocols and ensuring effective communication between AHRI as the coordinating center and the participating sites. 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:
• • Performs a variety of supervisory duties related to the management, performance, evaluations, development conversations, timekeeping, and workflow of the Regulatory Specialists team.
• Supervise the work assignments, priorities, and productivity, including the development of training processes and materials of the Regulatory Specialists team.
• Serves as a preceptor for all new study coordinators, including the development of training processes and material.
• Provides guidance and mentorship to promote growth for study team members, including those in new positions.
• Responsible for submissions 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, as applicable.
• Provides data and document collection and compilation for regulatory filing with the FDA and other regulatory authorities.
• May provide technical review and report preparation and submission of FDA required reports of ongoing AdventHealth sponsored and held IND/IDE applications.
• Coordinates regulatory processes and submissions for AdventHealth led multi-site research.
The expertise and experiences you’ll need to succeed :
+ Minimum qualifications :
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)
+ Work experience includes documented experience in submitting and maintaining research essential regulatory documents, working with Central Institutional Review Boards, financial conflicts of interest, and/or ClinicalTrials.gov, and experience with FDA and/or NIH audits; AND
+ Bachelor’s degree in healthcare related field or biological sciences; and at least five (5) years applicable work experience in the research regulatory field (working in a clinical research or scientific setting; OR
+ Associate Degree and at least seven (7) years applicable work experience in the research regulatory field (working in a clinical research or scientific setting)
+ Experience in management and/or teaching or training of employees.
+ Preferred qualifications:
o Experience in providing research regulatory support in a National Cancer Institute (NCI) designated cancer center.
o Master’s degree in healthcare related field or biological sciences
o Experience submitting IND/IDE applications to the FDA and/or supporting research investigators functioning in a Sponsor-Investigator role who hold an IDE or IND.
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: 24036583
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.
Source : AdventHealth
