IRB & Research Compliance Specialist

Highmark Health; Elm (PA); On-site; USD 36,000 - 56,000; Full time

Job summary

Allegheny Health Network is seeking an IRB Coordinator to ensure strict adherence to federal regulations (FDA/ NIH) in the review and approval of research protocols involving human subjects.

You will plan and manage IRB activities, guide researchers on submissions and amendments, review exempt or expedited protocols, and maintain the IRB database while upholding HIPAA and institutional privacy policies.

Compliance with all regulatory agencies and company policies is fundamental to this role.

Qualifications

• Bachelor's degree in Health Sciences or related field
• 3 years recent IRB or clinical research coordinator experience

Responsibilities

• Plans and manages all activities pertaining to the IRB review and approval process of all research protocols involving human subjects.
• Directs researchers regarding protocol submission, corrections to medical and technical deficiencies or protocols, informed consent documents, amendments, etc.
• Reviews independently protocols submitted for exempt or expedited review based on clinical expertise/training.
• Maintains the IRB database.
• Maintains compliance with regulatory agencies, institutional policy, procedures, guidelines, and federal regulations.

Skills

IRB experience

Regulatory compliance

Clinical research coordination

Education

Bachelor's degree in Health Sciences or related field

CIM

CRC

Certified IRB Professional (CIP)

Certified IRB Manager

Job description

Allegheny Health Network is seeking an IRB Coordinator to ensure strict adherence to federal regulations (FDA/ NIH) in the review and approval of research protocols involving human subjects.

You will plan and manage IRB activities, guide researchers on submissions and amendments, review exempt or expedited protocols, and maintain the IRB database while upholding HIPAA and institutional privacy policies.

Compliance with all regulatory agencies and company policies is fundamental to this role.