Duties:

Oversee clinical research regulatory operations.

Ensure compliance with industry standards and regulations.

Facilitate study start-up approval and maintain regulatory documentation.

Serve as the central resource for regulatory compliance.

Manage day-to-day regulatory operations and ensure study compliance.

Oversee informed consent process and ensure consistency with CTA language.

Develop systems for organizing regulatory activities.

Communicate regulatory updates to the study team.

Work with the Director of Clinical Research – Finance & Regulatory.

Provide institutional authorization for new IRB submissions.

Track and streamline IRB/subcommittee approval processes.

Register and maintain clinical trials on ClinicalTrials.gov.

Maintain study management in the clinical trial management system.

Ensure the institution's Federal Wide Assurance is current.

Develop and maintain SOPs, work instructions, forms, and templates.

Skills:

Excellent communication and organizational skills.

Knowledge of FDA and Medicare regulations and clinical trial guidelines.

Familiarity with Clinical Research study protocols and SOPs.

Qualifications:

Minimum of 5 years of regulatory experience.

3-5 years of management experience.

Preferably experienced in smaller/private clinic settings.

Comfortable managing a high volume of trials (175) and a staff of 5.

Cancer, WCG Ibarra experience preferred.

Education:

High School Graduate or equivalent.

Bachelor's Degree or 5+ years' experience in Clinical Research.