Regulatory Compliance Specialist - Cancer Clinical Trials

Overview

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 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 position maintains documentation for clinical research studies, case report forms and study and regulatory files. Under the direct supervision from the 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.

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

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

Responsibilities

PEOPLE ESSENTIAL FUNCTIONS

• Builds and maintains effective relationships with key study personnel.

• Acts as a liaison between the institutional review committees, regulatory agencies, and the investigators to ensure that protocols are approved, and that supplementary information is provided in a timely fashion as requested.

• Assists in training study personnel and others on regulatory and safety reporting processes, and procedures under the direct supervision of the Manager or Director (serves as a resource for regulatory information and guidance).

• Contributes towards improvement of department scores for employee engagement, i.e. peer-to-peer accountability.

SERVICE ESSENTIAL FUNCTIONS

• Ensures compliance of general and study-specific regulatory and/or safety-related processes with SOP's, FDA, GCP, NIH and applicable regulations.

• Assists in the preparation of research protocols for IRB submission, submitting protocol amendments, preparing renewals, preparing necessary regulatory documents for submission to study sponsors. Submits adverse event reports, safety reports, and notifies IRB of study closures.

• Maintains the required regulatory files for all clinical trials to ensure regulatory compliance. Meets with study monitors. Maintains archived documents on and off site.

• May assist in the preparation of periodic reports for FDA.

QUALITY/SAFETY ESSENTIAL FUNCTIONS

• Provide routine updates and reporting to the Manager or Director to ensure timely communication regarding status of regulatory and/or important safety related issues.

• Perform high quality clinical review of regulatory forms and associated documentation (during internal monitoring or review of trials).

• Prepare and manage documents required to initiate investigational drugs trials.

• Maintain a professional and c