Senior Regulatory Compliance Specialist

Overview

At Houston Methodist, the Senior (Sr.) Regulatory Compliance Specialist position is responsible for leading, 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 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. The Sr Regulatory Compliance Specialist position contributes directly to internal departmental monitoring and research education as identified by the Manager or Director.

Houston Methodist Standard

PATIENT AGE GROUP(S) AND POPULATION(S) SERVEDRefer to departmental "Scope of Service" and "Provision of Care" plans, as applicable, for description of primary age groups and populations served by this job for the respective HM entity.

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.

• Practices the Caring and Serving Model

• Delivers personalized service using HM Service Standards

• Provides for exceptional patient/customer experiences by following our Standards of Practice of always using Positive Language (AIDET, Managing Up, Key Words)

• Intentionally collaborates with other healthcare professionals involved in patients/customers or employees' experiential journeys to ensure strong communication, ease of access to information, and a seamless experience.

• Involves patients (customers) in shift/handoff reports by enabling their participation in their plan of care as applicable to the given job

• Displays cultural humility, diversity, equity and inclusion principles

• Actively supports the organization's vision, fulfills the mission and abides by the I CARE values

Responsibilities

PEOPLE ESSENTIAL FUNCTIONS

• 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 (serves as a resource for regulatory information and guidance)

• Develops and maintains interpersonal relationships with a wide variety of healthcare professionals and hospital leadership. Maintains credibility with IRB and other regulatory agencies, Sponsors, vendors, patients, and co-workers

• Role models behaviors that are congruent with cultural diversity, equity, and inclusion principles. Initiate's improvement recommendations for department scores for employee engagement, i.e., peer-to-peer accountability

SERVICE ESSENTIAL FUNCTIONS

• Serves as subject matter expert in support of department functions. Defines problems, collects data, establishes facts, and draws valid conclusions and evidence-based performance improvement via measurable results

• Prepare and manage documents required to initiate investigational drugs trials. Prepares research protocols for IRB submission, submits protocol amendments, prepares renewals and necessary regulatory documents for submission to study sponsors. Submits adverse event reports, safety reports, and notifies IRB of study closures

• Interfaces as needed with appropriate governmental agency on project/products as identified by the Manager. Assists in the preparation of periodic reports for FDA

• Develops appropriate regulatory reports and associated docu