Title:  Regulatory Affairs Associate - Clinical Research

Summary

The Office of Surgical Research (OSR) within the Michael E. DeBakey Department of Surgery is looking for a Regulatory Affairs Associate.  They will be responsible for coordinating the regulatory and administrative requirements for conducting clinical and translational research in 12 divisions. The Regulatory Affairs Associate will guide faculty developing regulatory documentation and serve as main contact for sponsors, government agencies, and the IRB.  The ideal candidate should be acquainted with FDA and HHS Regulations relating to Good Clinical Practice and Clinical Trials. Must be able to work well in a group as well as independently and have strong organizational skills. Be proficient in using regulatory databases, document management systems, and Microsoft Office Suite. Additionally, working knowledge of investigational device clinical trials and commercial IRB submissions is preferred.

Job Duties

• Prepares, compiles, and reviews regulatory documents (e.g., applications, amendments, protocols, and investigator brochures) following regulatory guidelines and internal standards.
• Facilitates internal and external audits and inspections related to regulatory compliance.
• Develops and implements corrective and preventive actions resulting from audits and inspections.
• Tracks submission status, maintain communication with regulatory authorities, and provide progress updates to internal stakeholders.
• Assists in developing training materials and educational resources to enhance regulatory awareness. 
• Manages regulatory work for research studies and clinical trials.
• Interprets and stays current with relevant regulations, guidelines, and industry standards.
• Assists investigators on their compliance with federal and international regulatory requirements, obligations and responsibilities that govern the conduct of clinical research studies.
• Liaises with sponsors, government agencies, and the IRB to develop regulatory documentation to ensure adherence to college policies and regulatory standards.
• Prepares, compiles and reviews regulatory submissions, renewals, monitoring, reporting of adverse events and audits.

Minimum Qualifications

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

Preferred Qualifications

• Bachelor's or Master's degree in a scientific discipline.
• Current certification (Certified Clinical Research Professional-CCRP, Certified Clinical Research Coordinator-CCRC) from a clinical research organization (SoCRA or ACRP).
• Regulatory Affairs experience within the pharmaceutical, biotechnology, or clinical research industry, with a preferred emphasis on clinical trials.
• A robust comprehension of regulatory requirements, encompassing ICH-GCP guidelines, local regulations, and international guidelines such as FDA and EMA.
• Excellent organizational expertise, demonstrated by concurrently managing numerous tasks and deadlines.
• A keen eye for detail and unwavering accuracy when handling documentation.
• Exceptional communication and interpersonal skills, showcasing the ability to collaborate with cross-functional teams effectively.