Institutional Review Board Specialist I

1103 Team Member Services; United States; On-site; USD 33,000 - 62,000; Full time

Benefits offered by this job

Medical Insurance

Vision Insurance

Dental Insurance

PTO from Day One

403-B Retirement Plan

Parental Leave

Career Development

Well-being Resources

Job summary

AdventHealth in Orlando, FL seeks an IRB Specialist to review submissions for new studies, modifications, and renewals. You will interpret state and federal regulations, determine review level, and coordinate with IRB chairs, physicians, and study teams to ensure timely, compliant approvals.

The role requires strong written and verbal communication, attention to detail, and the ability to work under pressure. A CIP is preferred, with a background in healthcare research advantageous.

Qualifications

• 2+ years of IRB-related experience (preferred).
• Knowledge of CFR, Common Rule, and HIPAA in human subjects research.
• Strong written and verbal communication skills.
• Proficiency with MS Office and research tools.

Responsibilities

• Review submissions to determine approval level and whether they can be approved.
• Interact with IRB manager, Chair, members, physicians, researchers and study teams daily.
• Coordinate with regulatory core to ensure information is accurate and complete.
• Explain policies and procedures to investigators and staff.
• Attend committee meetings and provide guidance on regulatory compliance.
• Assume other duties as assigned.

Skills

Attention to detail

Interpersonal skills

Team player

Written and verbal communication

MS Office proficiency

Regulatory knowledge

Education

Associate degree

Bachelor's degree (Preferred)

Tools

IRB databases

MS Outlook

Job description

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.

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 Schedule: Full time Shift: Day (United States of America) Address: 601 E ROLLINS ST City: ORLANDO State: Florida Postal Code: 32803

Job Description

Applies applicable regulations and makes decisions on whether submissions can be approved, including new studies, modifications, and annual renewals. Develops knowledge through training in state and federal laws and regulations, ethical issues, institutional policies, and other agency requirements governing the protection of human subjects in research. Provides review to make decisions on the level of review and assigns reviews to IRB members. Interacts directly with IRB manager, IRB Chair, IRB members, physician researchers, other researchers, and study teams daily to facilitate the research review process. Facilitates the 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. Communicates policies and procedures in research administration. Reads and interprets current regulations, guidelines, and trends influencing the conduct of human subject research. Interacts with management and staff to provide useful information, guidance, and integrity to human subject research activities. Monitors, reviews, and reports on performance measures, and audits and monitors studies and consent processes. Counsels investigators and support staff in resolving IRB committee contingencies. Attends committee meetings and serves as a resource on human subject research regulations and institutional requirements for committee members and Chairs. Other duties as assigned.

Knowledge, Skills, and Abilities

• Motivated, organized and able to function independently [Required]
• Excellent interpersonal skills and a collaborative style necessary for interaction across departments. [Required]
• Team player. [Required]
• Advanced written and verbal communication skills with demonstrated proficiency for current spelling, grammar, tone, and syntax [Required]
• Proficient in MS Office Suite (Outlook, Word, Excel, Publisher, PowerPoint, etc.), internet, and other research tools, word-processing and databases [Required]
• Ethical and diplomatic with an ability to provide excellent customer service. [Required]
• Ability to work under pressure, meet fixed deadlines, and manage competing priorities [Required]
• Understanding of the U.S. Code of Federal Regulations (CFR), ethical issues, institutional policies, and other agency requirements which govern the protection of human subjects in research (The Common Rule (45CFR46), Food and Drug Administration (FDA) (21CFR50,56, HIPAA, Good Clinical Practice, the Declaration of Helsinki, and the Belmont Report) [Preferred]
• Knowledge of medical terminology [Preferred]
• Knowledge of the conduct of human subject research. [Preferred]
• Knowledge of AdventHealth policies and procedures related to human subject research and research administration [Preferred]
• Working knowledge of IRB related database software applications [Preferred]

Education

• Associate [Required]
• Bachelor's [Preferred]

Field of Study

in legal studies, healthcare, business administration, finance, accounting, or research-related field

Work Experience

• 2+ years of IRB related experience preferably in an academic or medical setting [Preferred]

Additional Information

N/A

Licenses and Certifications

• Certified IRB Professional (CIP) [Preferred]
• Certified Institutional Review Board Professional (CIP) (CIP) [Preferred]

Physical Requirements

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

Pay Range

$23.94 - $44.53

Background Screening Requirement (Florida Law)

Certain positions are subject to Florida Level 2 background screening, including fingerprinting, as required by state law. Applicants may review general information about Florida’s background screening requirements at the Florida Care Provider Background Screening Clearinghouse: https://info.flclearinghouse.com/

This facility is an equal opportunity employer and complies with federal, state and local anti-discrimination laws, regulations and ordinances.

Every day, our fellow team members show up to work, unified by one shared mission: Extending the Healing Ministry of Jesus Christ. As a faith-based health care organization, our story is one of hope as we strive to heal and restore the body, mind and spirit. Though our facilities are spread across the country, this unwavering belief binds us together. Across every office, exam and patient room, we’re committed to providing individualized, holistic care. This is our Christian mission, and it inspires us to help make communities healthier and happier.