Regulatory Assistant - Clinical Research

Benefits

Qualifications

• •1-3 years of experience in clinical research/regulatory and familiarity with:
• •FDA regulations and ICH-GCP guidelines
• •IRB processes and submissions
• •High school diploma or equivalent
• •Strong organizational skills and attention to detail
• •Ability to manage multiple priorities in a fast-paced environment
• •Proficiency in Microsoft Office (Word, Excel, Outlook)
• •Strong written and verbal communication skills
• •clinical research regulatory: 1 year (Required)
• •Pearland, TX 77584 (Required)
• •7 more items(s)

Responsibilities

• •The Regulatory Assistant plays a critical support role within the Regulatory Department, assisting Regulatory Specialists in maintaining compliant, audit-ready study documentation across multiple clinical trials
• •This position is ideal for someone detail-oriented, organized, and interested in building a career in clinical research and regulatory affairs
• •Provide day-to-day administrative and regulatory support to the Regulatory Department
• •Maintain and organize regulatory binders (electronic and/or paper) in accordance with GCP, FDA, and sponsor requirements
• •Coordinate and file study-related documents including:
• •Protocol submissions and amendments
• •IRB submissions and approvals
• •Sponsor communications and correspondence
• •Regulatory responses and re-submissions
• •Track and maintain regulatory databases, logs, and internal systems
• •Assist with preparation and submission of regulatory documents to Institutional Review Boards (IRBs) and study sponsors
• •Support maintenance of the Delegation of Duties and Authority Log (DOAL), ensuring accuracy and completeness
• •Coordinate training documentation for study staff, including protocol-specific and amendment-related training
• •Assist in compiling regulatory metrics and reports for leadership review
• •Prepare for and participate in monitoring visits, audits, and inspections
• •Collaborate closely with Regulatory Specialists, Clinical Research Coordinators, investigators, and study staff to ensure regulatory compliance
• •Attend research team meetings and provide status updates on regulatory submissions and approvals
• •Perform additional administrative or regulatory tasks as assigned
• •Full-time, Monday–Friday (8:00 AM – 5:00 PM)
• •16 more items(s)