Clinical Research Regulatory Lead

DM Clinical Research; Houston (TX); On-site; USD 60,000 - 80,000; Full time

Job summary

A clinical research organization in Houston is seeking a Clinical Research Regulatory Specialist to provide regulatory oversight for clinical trials. The position involves preparing and coordinating IRB applications, ensuring compliance with regulations, and maintaining audit-ready regulatory binders. Ideal candidates have a Bachelor's Degree, at least one year of experience as a Clinical Research Coordinator, and strong communication and leadership skills. This role supports maintaining high standards during audits.

Qualifications

• At least one year of experience as a Clinical Research Coordinator (CRC).
• Proven leadership skills in project management.
• Experience in FDA, IRB administration, and regulatory affairs.

Responsibilities

• Prepare and coordinate IRB applications for protocol revisions.
• Ensure submission packets meet IRB's requirements.
• Coordinate the preparation and submission of consent forms.

Skills

Strong written and oral communication skills

Strong computer skills, including Microsoft Office, Excel, and PowerPoint

Time management

Leadership skills

Education

Bachelor's Degree

Job description

A clinical research organization in Houston is seeking a Clinical Research Regulatory Specialist to provide regulatory oversight for clinical trials. The position involves preparing and coordinating IRB applications, ensuring compliance with regulations, and maintaining audit-ready regulatory binders. Ideal candidates have a Bachelor's Degree, at least one year of experience as a Clinical Research Coordinator, and strong communication and leadership skills. This role supports maintaining high standards during audits.