IRB & Research Compliance Specialist

Highmark Health; New York (NY); On-site; USD 36,000 - 56,000; Full time

Job summary

Allegheny Health Network seeks an IRB Coordinator to oversee all activities related to the review and approval of research protocols involving human subjects. You will guide researchers through submissions, corrections, and consent documents while ensuring regulatory compliance and maintaining the IRB database.

The role emphasizes independent review of exempt or expedited protocols and strict adherence to HIPAA and institutional policies. Strong regulatory knowledge is essential.

Qualifications

• Bachelor's degree in Health Sciences or related field required.
• 3 years of IRB or clinical research coordinator experience preferred.
• CIP or CIP related certification is a plus.

Responsibilities

• Plans and manages all activities pertaining to the IRB review and approval process for research protocols involving human subjects.
• Provides direction to researchers regarding protocol submission, corrections, and informed consent documents.
• Reviews exempt or expedited reviews based on clinical expertise.
• Maintains the IRB database and ensures regulatory compliance.
• Maintains compliance with all applicable laws, policies, and guidelines.

Skills

IRB experience

Clinical research coordination

Education

Bachelor's degree in Health Sciences or related field

3 years IRB or clinical research coordinator experience

Job description

Allegheny Health Network seeks an IRB Coordinator to oversee all activities related to the review and approval of research protocols involving human subjects. You will guide researchers through submissions, corrections, and consent documents while ensuring regulatory compliance and maintaining the IRB database.

The role emphasizes independent review of exempt or expedited protocols and strict adherence to HIPAA and institutional policies. Strong regulatory knowledge is essential.