Summary

The Office of Surgical Research (OSR) within the Michael E. DeBakey Department of Surgery is seeking a Regulatory Affairs Associate to support all aspects of regulatory compliance for conducting translational and clinical research.

Under the supervision of the Clinical Research Manager, the Regulatory Affairs Associate will be responsible for coordinating the regulatory and administrative requirements for conducting research and assisting in the management of multi-faceted, complex investigator-initiated treatment protocols and industry-sponsored protocols. This position supports all aspects of regulatory compliance for both therapeutic drug and device trials. The role is expected to collaborate with other academic centers, NIH funded consortia, the Federal Drug Administration (FDA), and industry sponsors.

This role will provide comprehensive support to the department's investigators in ensuring regulatory compliance throughout the clinical trial life cycle, including study start-up, study initiation, ongoing study compliance, and study close-out.

Job Duties

Regulatory Submissions:

• Prepare, compile, and review regulatory documents (e.g., applications, amendments, protocols, investigator brochures) following regulatory guidelines and internal standards.
• Coordinate timely submission of regulatory documents to authorities, ensuring compliance.
• Track submission status, maintain communication with regulatory authorities, and provide progress updates to internal stakeholders.

Compliance and Documentation:

• Stay updated on local, regional, and international regulations, guidelines, and industry best practices related to clinical trial conduct and regulatory affairs.
• Assist in developing and implementing regulatory strategies and procedures for compliance.
• Collaborate with cross-functional teams to ensure regulatory compliance throughout the trial lifecycle.
• Maintain and update regulatory documentation, including binders, study files, and databases, ensuring accuracy and accessibility.

Quality Assurance:

• Support internal and external audits and inspections related to regulatory compliance.
• Assist in implementing corrective and preventive actions (CAPAs) resulting from audits and inspections.
• Participate in developing and maintaining quality management systems for regulatory affairs.

Regulatory Intelligence:

• Provide guidance and recommendations on regulatory requirements and their impact on clinical trial activities.
• Assist in developing training materials and educational resources to enhance regulatory awareness.

Other:

• Performs other job-related duties as assigned.

Minimum Qualifications

• Bachelor's degree.
• Two years of relevant experience.

Preferred Qualifications

• Master's degree in a scientific discipline or related field.
• Minimum of 2 years of regulatory affairs experience in the pharmaceutical, biotechnology, or clinical research industry, preferably with a focus on clinical trials.
• Strong understanding of regulatory requirements, including ICH-GCP guidelines, local regulations, and international guidelines (e.g., FDA, EMA).
• Excellent organizational skills, with the ability to manage multiple tasks and deadlines concurrently.
• Attention to detail and accuracy in documentation.
• Effective communication and interpersonal skills, with the ability to collaborate with cross-functional teams.
• Proficiency in using regulatory databases, document management systems, and Microsoft Office Suite.
• Familiar with FDA and HHS Regulations relating to Good Clinical Practice and Clinical Trials.
• Able to work well in a group as well as independently and have strong organizational skills.
• Knowledge of investigation device clinical trials and commercial IRB submissions is preferred.
• Current certification (Certified Clinical Research Professional-CCRP, Certified Clinical Research Coordinator-CCRC) from a clinical research organization (SoCRA or ACRP).