Regulatory Affairs Specialist: Research Protocols

cincinnatichildrens; Cincinnati (OH); On-site; USD 57,000 - 72,000; Full time

Job summary

Cincinnati Children's IRB/Regulatory Compliance Specialist role in the Hematology Department focuses on protocol review and ensuring adherence to federal, state, and institutional guidelines.

You will coordinate amendments, SAE reports, and continuing reviews, while maintaining accurate electronic regulatory records and collaborating with investigators and staff to promote ethical practices in human subjects research.

Qualifications

• Bachelor's degree in a related field
• 2+ years of work experience in a related job discipline

Responsibilities

• Protocol - Analyze research protocols submissions to determine compliance with regulations and oversee the review and correspondence of protocols.
• Compliance - Conduct pre-reviews and advise investigators regarding regulatory, ethical, editorial or content issues; coordinate outside expert reviews when needed.
• Process - Prepare for audits, surveys, quality reviews, and inspections; contribute to improving organizational performance and developing guidelines and training materials.
• Procedure - Act as a resource for faculty and staff regarding regulations during protocol review and maintain currency in the field.
• Documentation - Document the conduct of each protocol's regulatory activities in an electronic regulatory system and submit data to collaborators accurately.

Education

Bachelor's degree in a related field

Job description

Cincinnati Children's IRB/Regulatory Compliance Specialist role in the Hematology Department focuses on protocol review and ensuring adherence to federal, state, and institutional guidelines.

You will coordinate amendments, SAE reports, and continuing reviews, while maintaining accurate electronic regulatory records and collaborating with investigators and staff to promote ethical practices in human subjects research.