Regulatory Affairs Associate

1w1 week ago

Baylor College of Medicine

Houston, US · Full-time · $65,000 – $85,000

About this role

The Regulatory Affairs Associate supports the Protocol Office and investigators associated with The Texas Children's Cancer and Hematology Centers (TXCH). This role manages all aspects of regulatory compliance for a specified portfolio of clinical trials. It includes reviewing protocols, submitting to regulatory agencies and review committees, and ensuring successful approval processes.

Daily responsibilities involve coordinating regulatory correspondence across internal stakeholders and external institutions. The associate prepares protocol documents and forms for institutional and agency approvals. They act as a liaison to facilitate approvals, amendments, and renewals while maintaining regulatory databases and study files.

This position works closely with study teams, research staff, and investigators to keep documents up-to-date and audit-ready. It develops positive relationships with institutional review committees and sponsors through communications. The role assures distribution of information between investigators, agencies, and staff for research implementation.

Employees maintain knowledge of federal regulations, ICH GCP guidelines, and SOPs through continuing education. Preparation for FDA meetings, inspections, and audits is essential, including onsite availability. Certification pay is available for Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC).

Requirements

Detailed understanding of clinical research and applicable regulations
Knowledge of federal regulations, ICH GCP guidelines, and internal SOPs
Working knowledge of regulatory requirements through independent continuing education
Ability to maintain and expand understanding by producing compliant work
Experience providing input on consent form creation and protocol editing
Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) certification

Responsibilities

Coordinates regulatory correspondence across internal stakeholders and external institutions
Prepares protocol documents and required regulatory forms to obtain institutional and regulatory agency approval
Acts as a liaison between institutional review committees, regulatory agencies, and investigators for approvals and amendments
Facilitates investigators in reporting and responding to institutional review committees' and regulatory agencies' inquiries
Facilitates communication with IRB and other agencies related to Adverse Events and Unanticipated Problems reporting
Maintains electronic and paper study files in accordance with local SOPs, sponsor, and industry standards
Prepares for FDA meetings, inspections, and audits from regulatory authorities
Participates in feasibility, implementation, site initiation meetings, and research audits