Research Integrity & IRB Compliance Specialist

Highmark Health Company; Pennsylvania; Hybrid; USD 36,000 - 56,000; Full time

Job summary

Allegheny Health Network is seeking a qualified IRB Coordinator to ensure compliance with federal regulations (FDA/NIH) throughout the review and approval process for human subjects research protocols. The role involves guiding researchers on submissions, managing the IRB review process, and maintaining regulatory compliance and IRB databases.

The ideal candidate will have a Bachelor's degree in Health Sciences or related field, at least 3 years of IRB/clinical research coordinator experience,

Qualifications

• Minimum Bachelor's degree in Health Sciences or related field or relevant experience as determined by the company.
• 3 years recent IRB or clinical research coordinator experience.
• Preferred CIM or CRC Certified IRB Professional (CIP) certification.

Responsibilities

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

Skills

Regulatory compliance

IRB processes

Education

Bachelor's degree in Health Sciences or related field

Job description

Allegheny Health Network is seeking a qualified IRB Coordinator to ensure compliance with federal regulations (FDA/NIH) throughout the review and approval process for human subjects research protocols. The role involves guiding researchers on submissions, managing the IRB review process, and maintaining regulatory compliance and IRB databases.

The ideal candidate will have a Bachelor's degree in Health Sciences or related field, at least 3 years of IRB/clinical research coordinator experience,