Research Regulatory Specialist

Research Regulatory Specialist Cancer and Blood Specialty Clinic - 1.6 Los Alamitos, CA Job Details Full-time $25 - $30 an hour 23 hours ago Benefits Health insurance Dental insurance 401(k) Paid time off Vision insurance Qualifications Regulatory inspections Record keeping Clinical research Research ethical considerations Achieving HIPAA compliance Writing skills Compliance audits & assessments HIPAA Filing Corrective and preventive actions (CAPA) Mid-level Master's degree High school diploma or GED ICH guidelines Bachelor's degree Task prioritization Staff training Mentoring Research compliance clinical trial records management Organizational skills Regulatory submissions Research regulatory compliance Productivity software Training & development IRB compliance 2 years Communication skills Hospital experience Internal audits FDA regulations Full Job Description

JOB PURPOSE

The Research Regulatory Specialist is responsible for coordinating, preparing, and maintaining regulatory documentation for clinical research studies in compliance with institutional, federal, and sponsor requirements. This role ensures the timely submission of regulatory documents, facilitates communication between sponsors, investigators, and regulatory bodies, and supports the ethical and compliant conduct of human subjects research.

ESSENTIAL JOB FUNCTIONS

Prepare and submit regulatory documents (e.g., IRB submissions, protocol amendments, informed consent forms, safety reports, continuing reviews) in accordance with applicable regulations and institutional policies. Maintain up-to-date regulatory binders and electronic regulatory files for all assigned studies. Track and ensure timely submission of protocol renewals, modifications, and reportable events to the IRB and other regulatory agencies. Serve as the primary liaison between research sponsors, contract research organizations (CROs), investigators, and institutional regulatory offices. Assist investigators and research staff with the development and submission of regulatory materials. Ensure compliance with ICH-GCP, FDA, and HIPAA regulations governing clinical research. Support study start-up activities including site initiation and training documentation. Coordinate with clinical research coordinators to ensure protocol adherence and regulatory compliance. Monitor expirations of essential documents (e.g., investigator credentials, training certificates) and ensure timely renewal. Participate in internal audits and regulatory inspections; prepare audit responses and corrective action plans when necessary. Provide training and guidance to new staff or research team members on regulatory requirements and documentation standards.

QUALIFICATIONS AND EXPERIENCE

Education:

Bachelor's degree in a health-related, life sciences, or regulatory affairs field required. Master's degree or clinical research certification (e.g., SOCRA, ACRP) preferred.

Experience:

Minimum of 2-3 years of experience in clinical research regulatory affairs or IRB coordination. Familiarity with FDA, ICH-GCP, and HIPAA regulations. Experience working in an academic, hospital, or research site setting preferred.

Skills:

Strong knowledge of clinical trial regulatory processes and documentation. Excellent written and verbal communication skills. Strong organizational skills and attention to detail. Ability to prioritize multiple tasks and meet strict deadlines. Proficiency with Microsoft Office and electronic regulatory management systems (e.g., OnCore, IRBNet, REDCap, or similar platforms).

WORKING CONDITIONS AND PHYSICAL REQUIREMENTS

Standard office setting with prolonged periods of sitting and computer use. Occasional standing, walking, or lifting up to 10 lbs. May require limited travel to off-site research locations or meetings. Must be able to work occasional evenings or weekends during audit preparation or study deadlines.

DIRECT REPORTS

This position does not have direct reports but may provide training or mentorship to junior research staff or interns.

Job Type:

Full-time Pay:

$25.00 - $30.00 per hour

Benefits:

401(k) Dental insurance Health insurance Paid time off Vision insurance

Education:

High school or equivalent (Preferred)

Experience:

oncology/hematology: 1 year (Preferred) Clinical research: 1 year (Preferred) Ability to

Relocate:

Los Alamitos, CA 90720: Relocate before starting work (Required)

Work Location:

In person