Clinical Research Regulatory Coordinator (IRB & Compliance)

Arkansas Children’s Hospital; Little Rock (AR); On-site; USD 40,000 - 70,000; Full time

Job summary

Arkansas Children's Hospital is seeking a Regulatory Affairs professional to oversee all regulatory matters for researchers within Arkansas Children's Research Institute. You will ensure compliance with federal/state rules, IRB oversight, and institutional policies governing human subjects research.

The role involves preparing IRB documents, coordinating site initiation visits, and maintaining regulatory drafts with accuracy, while staying compliant with training requirements and collaborating

Qualifications

• Prepares and submits IRB documents under the direction of the PI/Research Administrator.
• Assists with submitting documents and contracts through regulatory and IRB processes.
• Performs high quality review of start-up regulatory forms and associated documentation prior to submission.
• Coordinates and participates in pre-site and site initiation visits and planning of source documents.
• Manages and proofreads updated study regulatory drafts for accuracy and completeness.
• Complies with all Office of Compliance training requirements.
• Communicates review board decisions or compliance issues to researchers and teams.
• Negotiates revisions with researchers and sponsors to facilitate review and approval.
• Attends conferences and participates in study-related meetings.
• Performs other duties as assigned.

Responsibilities

• Prepares and submits IRB documents under PI/Administrator direction.
• Assists with regulatory and IRB submissions and sponsor communications.
• Reviews startup regulatory forms prior to submission to sponsor/IRB.
• Coordinates site initiation visits and planning of source documents.
• Maintains accuracy of regulatory drafts and changes.
• Ensures compliance with training requirements.
• Communicates board decisions and compliance issues to researchers.
• Negotiates revisions to facilitate review board approval.
• Participates in conferences and study-related meetings.
• Performs other duties as assigned.

Skills

IRB knowledge

Regulatory compliance

Documentation review

Communication skills

Education

High school diploma or GED

Bachelor's degree in related field

Certified Clinical Research Professional (CCRP)

Job description

Arkansas Children's Hospital is seeking a Regulatory Affairs professional to oversee all regulatory matters for researchers within Arkansas Children's Research Institute. You will ensure compliance with federal/state rules, IRB oversight, and institutional policies governing human subjects research.

The role involves preparing IRB documents, coordinating site initiation visits, and maintaining regulatory drafts with accuracy, while staying compliant with training requirements and collaborating