Regltry Complnc Specialist (Houston)

Regulatory Compliance Specialist

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) SERVED

Refer 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

SERVICE ESSENTIAL FUNCTIONS

QUALITY / SAFETY ESSENTIAL FUNCTIONS

FINANCE ESSENTIAL FUNCTIONS

GROWTH / INNOVATION ESSENTIAL FUNCTIONS

This job description is not intended to be all-inclusive; the employee will also perform other reasonably related business / job duties as assigned. Houston Methodist reserves the right to revise job duties and responsibilities as the need arises.

Qualifications

EDUCATION

WORK EXPERIENCE

License / Certification

LICENSES AND CERTIFICATIONS - REQUIRED

LICENSES AND CERTIFICATIONS - PREFERRED

KSA / Supplemental Data

KNOWLEDGE, SKILLS, AND ABILITIES