Senior Regulatory Compliance Specialist

At Houston Methodist Academic Institute, we are seeking a highly skilled and experienced Senior Regulatory Compliance Specialist to join our team. As a key member of our research and education initiatives, you will play a critical role in ensuring compliance with regulatory requirements and guidelines.

• Lead and coordinate study-specific regulatory processes, including local IRB submissions and external IRB submissions, in compliance with Good Clinical Practices (GCP) and all local, state, and federal laws, regulations, guidance, policy, and procedure.
• Work closely with industry sponsors and grant funders to ensure regulatory compliance and maintain accurate documentation for clinical research studies, case report forms, and study and regulatory files.
• Collaborate with cross-functional teams, including research coordinators, clinical trial managers, and principal investigators, to ensure cohesive and smooth operation of the department.
• Develop and maintain interpersonal relationships with healthcare professionals, hospital leadership, and regulatory agencies to maintain credibility and ensure compliance.

• Bachelor's degree or higher in a relevant field.
• Five years of experience in relevant research program experience.
• RAC, CCRC, or CCRP certification preferred.

• A dynamic and collaborative work environment.
• Opportunities for professional growth and development.
• A competitive salary and benefits package.

Houston Methodist Academic Institute is an equal opportunity employer, committed to diversity and inclusion. We welcome applications from qualified candidates who share our values and are passionate about delivering exceptional patient care and advancing medical research.