Regulatory Compliance Specialist - Transplant Center

At Houston Methodist, the Regulatory Compliance Specialist position is responsible for coordinating and performing study‑specific regulatory processes such as local IRB submissions in compliance with Good Clinical Practices (GCP) and all local, state, and federal laws, regulations, guidance, policy, and procedure developed by Houston Methodist Research Institute Institutional Review Board (IRB), Food and Drug Administration (FDA) Code of Federal Regulations (CFR), and the International Conference on Harmonization (ICH).

This position communicates with the regulatory affairs office for FDA submissions across multiple studies of different therapeutic areas and phases in accordance with appropriate regulations, Standard Operating Procedures (SOPs), and study‑specific protocols/plans and processes. The Regulatory Compliance Specialist maintains documentation for clinical research studies, case report forms, and study and regulatory files. Under the direct supervision of management, this position addresses problem‑solving issues of moderate to complex scope and assists with internal departmental monitoring and research education as identified by the Manager or Director.

FLSA Status: Exempt

• Education: Bachelor’s degree or higher
• Experience: Two years of clinical research, regulatory compliance, or equivalent applicable work experience within an academic research environment or FDA regulated industry. Experience in medical devices, diagnostics, or pharmaceuticals and/or within an academic medical center setting highly preferred.
• Preferred
  
  Certifications:
  
  
  • RAC
    - Regulatory Affairs Certifications (RAPS)
  • CCRC
    - Certified Clinical Research Coordinator (ACRP)
  • CCRP
    - Certified Clinical Research Professional (SOCRA)

• Demonstrates the skills and competencies necessary to safely perform the assigned job, determined through ongoing skills, competency assessments, and performance evaluations.
• Proficient speaking, reading, and writing English; necessary for activities impacting patient or employee safety or security.
• Effectively communicates with patients, physicians, family members, and coworkers with a customer‑service focus and positive language principles.
• Knowledge and application of process improvement tools and techniques (statistical process control and team tools).
• Knowledge of regulatory and accrediting standards as they apply to performance improvement.
• Develops and maintains interpersonal relationships with a wide variety of healthcare professionals and hospital leadership.
• Defines problems, collects data, establishes facts, and draws valid conclusions to drive measurable performance improvement.
• Has computer skills in Excel, Word, and PowerPoint and can enter, abstract, and use data to facilitate process improvement.
• Facilitates performance improvement teams, presents data, and promotes a collaborative approach to goal achievement.
• Works independently and interdependently; demonstrates presentation skills and expertise in designing and implementing educational offerings related to clinical quality.

• Builds and maintains effective relationships with key study personnel.
• Acts as a liaison between the institutional review committees, regulatory agencies, and investigators to ensure protocols are approved and supplementary information is provided timely.
• Assists in training study personnel and others on regulatory and safety reporting processes and procedures under direct supervision; serves as a resource for regulatory information and guidance.
• Contributes to improvement of departmental employee engagement scores (peer‑to‑peer accountability).

• Ensures compliance of general and study‑specific regulatory and/or safety‑related processes with SOPs, FDA, GCP, NIH, and applicable regulations.
• Assists in preparation of research protocols for IRB submission, submitting protocol amendments, preparing renewals, and preparing necessary regulatory documents for sponsor submission; submits adverse event reports, safety reports, and notifies IRB of study closures.
• Maintains required regulatory files for all clinical trials to ensure regulatory compliance,…