San Jose, California
Schenectady, New York
Posted: 29-Dec-22
Location: Tampa, Florida
Salary: Open
Categories:
Internal Number: 22045104
Description
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*
- Reimbursement for the NCLEX*
* 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: Days
Location: 3100 East Fletcher Avenue Tampa, Florida 33613
The community you’ll be caring for: AdventHealth Tampa
- AdventHealth Pepin Heart Institute, known across the country for its advances in cardiovascular disease prevention, diagnosis, treatment and research.
- Surgical Pioneers – the first in Tampa with the latest robotics in spine surgery
- Building a brand new, six story surgical and patient care tower which will ensure state of the art medical and surgical car for generations to come
- Awarded the Get With The Guidelines – Stroke GOLD Quality Achievement Award from the American Heart Association/American Stroke Association and have been recognized as a recipient of their Target: Stroke Honor Roll for our expertise in stroke care. We have also received certification by The Joint Commission in collaboration with the American Stroke Association as a Primary Stroke Center.
The role you’ll contribute:
The Senior IRB Specialist exercises objective and independent judgement to ensure uniformity of review and compliance with IRB standard operating procedures and applicable federal and state regulations while working collaboratively with the IRB Manager, staff and IRB Chair. The Senior IRB Specialist is knowledgeable in the areas of state and federal laws and regulations, ethical issues, institutional policies, and other agency requirements which govern the protection of human subjects in research. The Sr IRB Specialist conducts quality control functions for the IRB office that may extend to all areas of the operation including review of files and meeting minutes for completeness, accuracy and consistency. The position works to identify gaps and works directly with the IRB manager to develop policies and procedures. The Sr IRB Specialist takes on the lead for training IRB Office Coordinators, external IRB review processes, IRB electronic submission process and special projects as requested. Actively participates in outstanding customer service and accepts responsibility for maintaining relationships that are equally respectful to all.
The value you’ll bring to the team:
In coordination with the IRB Manager, orients, trains, provides guidance to new staff as well as to achieve departmental goals and objectives.
• Reads and interprets current regulations, guidelines, and trends influencing the conduct of human subject research.
• Serves as a subject matter expert across the AdventHealth System on matters pertaining to human subject research.
• Interacts with all levels of management and staff to provide useful information, guidance, and integrity to human subject research activities
• Has responsibility to act as acting IRB manager in the manager’s absence.
• Research, draft, review and assist with developing new procedures and changes to existing procedures.
• Monitor, review, and report on performance measures. Audit and monitor studies and consent process.
• Develop and conduct educational classes’ specific to human subject research to both researchers and IRB members.
• Counsels investigators and support staff in resolving IRB committee contingencies.
• Serves as an IRB voting member. Attend committee meetings and serve as a resource on human subject research regulations and institutional requirements for committee members and Chairs.
• Serve as the lead for training on the IRB electronic submission system. Provide guidance to research coordinators and investigators regarding applications in preparation for submission to FH IRB.
• Interacts directly with IRB manager, IRB Chair, IRB members, physician researchers, other researchers and study teams on a daily basis to facilitate the research review process.
• Exercises objective and independent review to makes decisions on level of review and assigns reviews to IRB members
• Applies applicable regulations and make decisions on whether submissions can be approved, when not submitted for convened board review. Includes new studies, modifications, annual renewals.
• Manages process that controls when studies can be reviewed by external IRBs.
• Works closely with the research regulatory core team to ensure information provided to the IRB within application forms and other documents is consistent and complete.
• Develops, updates and communicates policies and procedures in research administration.
QualificationsThe expertise and experiences you’ll need to succeed:
Bachelor’s degree in legal studies, healthcare, business administration, finance, accounting, or research-related field and five (5) years of IRB or research related experience preferably in an academic or medical setting; OR
• Associates degree in legal studies, healthcare, business administration, finance, accounting, or research-related field and seven (7) years of IRB or research related experience preferably in an academic or medical setting; OR
• Equivalent work consisting of at least eight (8) years of IRB or research related experience preferably in an academic or medical setting
EDUCATION AND EXPERIENCE PREFERRED:
• Master’s degree in legal studies, healthcare, business administration, finance, accounting, or research-related field
• Five (5) years of IRB or research related experience preferably in an academic or medical setting.
