Houston Methodist · 4 hours ago
Sr Regulatory Compliance Specialist
Houston, TX
Full-time
Onsite
Senior Level
5+ years expHouston Methodist is a leading academic institute focused on healthcare research and compliance. The Senior Regulatory Compliance Specialist is responsible for leading and coordinating regulatory processes for clinical research studies, ensuring compliance with relevant laws and regulations while maintaining documentation and communication with regulatory affairs.
Health CareMedical
Responsibilities
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)
Communicating 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
Maintaining documentation for clinical research studies, case report forms and study and regulatory files
Identifying problem-solving issues of moderate to complex scope under minimal supervision from the Manager or Director
Contributing directly to internal departmental monitoring and research education as identified by the Manager or Director
Collaborating with cross-functional teams including key study personnel to ensure cohesive, smooth operation of the department
Assisting in training regulatory personnel and others on regulatory and safety reporting regulations, processes, and procedures under the direct supervision of the Regulatory Compliance Manager
Developing and maintaining interpersonal relationships with a wide variety of healthcare professionals and hospital leadership
Initiating improvement recommendations for department scores for employee engagement, i.e., peer-to-peer accountability
Serving as subject matter expert in support of department functions
Preparing and managing documents required to initiate investigational drugs trials
Preparing research protocols for IRB submission, submitting protocol amendments, preparing renewals and necessary regulatory documents for submission to study sponsors
Submitting adverse event reports, safety reports, and notifying IRB of study closures
Interfacing as needed with appropriate governmental agency on project/products as identified by the Manager
Assisting in the preparation of periodic reports for FDA
Developing appropriate regulatory reports and associated documentation in accordance with SOPs and study specific processes under the direct supervision of the Regulatory Compliance Manager
Ensuring compliance of general and study-specific regulatory and/or safety-related processes with SOP’s, FDA, GCP, NIH and applicable regulations
Conducting internal reviews and audits to ensure compliance of regulatory forms and associated documentation
Serving 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
Utilizing resources with cost effectiveness and value creation in mind
Self-motivated to independently manage time effectively and prioritize daily tasks, assisting coworkers as needed
Seeking opportunities to identify self-development needs and takes appropriate action
Qualification
Required
Bachelor's degree or higher
Five years of experience in relevant research program experience
Must have one of the following certifications: RAC - Regulatory Affairs Certifications (RAPS) or CCRC - Certified Clinical Research Coordinator (ACRP) or CCRP - Certified Clinical Research Professional (SOCRA)
Demonstrates the skills and competencies necessary to safely perform the assigned job, determined through on-going skills, competency assessments, and performance evaluations
Sufficient proficiency in speaking, reading, and writing the English language necessary to perform the essential functions of this job, especially with regard to activities impacting patient or employee safety or security
Ability to effectively communicate with patients, physicians, family members and co-workers in a manner consistent with a customer service focus and application of positive language principles
Demonstrates expert knowledge and application of process improvement tools and techniques (statistical process control tools and team tools)
Demonstrates knowledge of regulatory and accrediting standards as they apply to performance improvement
Ability to enter and abstract data using personal computer, as well as the ability to utilize data to facilitate the improvement and change in processes
Ability to facilitate performance improvement teams, present data and promote a collaborative approach toward goal achievement
Ability to work independently and interdependently
Strong presentation skills and expertise in designing and implementing teams/educational offerings related to clinical quality
Preferred
Master's degree
Company
Houston Methodist
Houston Methodist is one of the nation’s leading health systems and academic medical centers.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Brooke Graham
CEO Project Director
David P. Bernard
Chief Executive Officer & Senior Vice President
Recent News
2025-12-07
Company data provided by crunchbase