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.
Additional Information: Ideal applicants will have prior work experience with FDA Form 1571 (Investigational New Drug Application (IND) submissions, e xpanded access protocol submissions under an existing Sponsor IND, s ubmitting a new expanded access IND submission for HM Neal Cancer CTR IIT's, and FDA Form 3926 submissions. Applicants with this experience will receive priority.
Requirements:
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
LICENSES AND CERTIFICATIONS - REQUIRED
LICENSES AND CERTIFICATIONS - PREFERRED
KNOWLEDGE, SKILLS, AND ABILITIES
SUPPLEMENTAL REQUIREMENTS
WORK ATTIRE
ON-CALL*
*Note that employees may be required to be on-call during emergencies (ie. DIsaster, Severe Weather Events, etc) regardless of selection below.
TRAVEL**
**Travel specifications may vary by department**
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