Senior Compliance Specialist

4 days ago


Niagara Falls, Ontario, Canada The Methodist Hospital Full time

Job Overview

The Senior Regulatory Compliance Specialist position is responsible for leading, coordinating, and performing study-specific regulatory processes in compliance with Good Clinical Practices (GCP) and all local, state, and federal laws, regulations, guidance, policy, and procedure developed by the 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 role 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 Sr. Regulatory Compliance Specialist position maintains documentation for clinical research studies, case report forms, and study and regulatory files. Under minimal supervision from the Manager or Director, this position identifies problem-solving issues of moderate to complex scope.

Houston Methodist Experience Expectations

  • Provide personalized care and service by consistently demonstrating our I CARE values:
  • INTEGRITY: We are honest and ethical in all we say and do.
  • COMPASSION: We embrace the whole person including emotional, ethical, physical, and spiritual needs.
  • ACCOUNTABILITY: We hold ourselves accountable for all our actions.
  • RESPECT: We treat every individual as a person of worth, dignity, and value.
  • EXCELLENCE: We strive to be the best at what we do and a model for others to emulate.

Responsibilities

  • Collaborates with cross-functional teams including key study personnel.
  • Role models strong, positive communication skills to ensure cohesive, smooth operation of the department.
  • Assists in training regulatory personnel and others on regulatory and safety reporting regulations, processes, and procedures under the direct supervision of the Regulatory Compliance Manager.
  • Develops and maintains interpersonal relationships with a wide variety of healthcare professionals and hospital leadership.


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