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Regulatory Compliance Specialist - OSRI Administration at Methodist

Posted in Compliance 30+ days ago.

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Type: Full Time
Location: Houston, Texas

Job Description:

Job Summary

This position is designed to provide specialized project and regulatory support to the Director of Regulatory Affairs and Translational Management (RATM) on various strategic projects. Under the guidance and direction of the Administrator/Director, the Regulatory Compliance Specialist will support administrative and project related duties of the department as assigned, including coordinating, operations, and completing projects related to regulatory submissions and early-stage translational research studies. The main duties for this role include: support in the initiation and execution of various preclinical and clinical investigations; tracking and analyzing key outcomes measures, coordinating team meetings and developing presentations for a variety of audiences. Utilizing a variety of internal and external data sources and software tools, the Regulatory Compliance Specialist serves a vital role in supporting the management team.


Not Applicable



* Works closely with Director and management team to help with daily operations

* Acts as interface with department liaisons for project analysis, status, technology or legal reviews

* Build and maintain effective relationships with key personnel in all research projects.

* Supports the department administration in process improvements and reducing expense.

* Maintain a professional and credible image with FDA and other regulatory agencies, researchers, external stakeholders, and co-workers.

* Maintains ICARE values and patient confidentiality


* May prepare detailed project plans, timelines and other tracking tools to assist in project coordination and monitoring of milestone completion.

* Analyzes and evaluates departmental budget requests to prepare budgetary documents

* Prepares charts and presentations from data provided to help guide strategic project developments and potential changes to scope or timeline

* Utilizes various computer information systems in the preparation of analyses and reports to evaluate in project feasibility

* Propose and implement solutions to support cost reduction enhancement


* Follows all safety rules while on the job. Reports accidents promptly and corrects minor safety hazards.

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


* Utilizes data gathering tools and methods to analyze and gather data needed for project requirements.

* Responsible for assisting in the preparation of necessary regulatory or research-related documentation for submission to internal, external stakeholders, and regulatory agencies.

* Offers administrative support to the implementation of the project. This includes communicating across multiple organizations and departments, ensuring progress toward the completion of key milestones, organizing meetings, sending meeting calendars, maintaining agendas and following up on action items as necessary to ensure completion of assignments.

* Tracks and analyzes key outcomes measures, identifies areas of opportunity, and communicates results clearly.

* Maintains associated paperwork, creates files, and develops effective presentation tools and/or reports for significant activities. Utilizes technology resources to conduct research for assigned projects.

* Assist in the preparation of correspondence, quarterly reports and other documentation relative to projects.


* Accountable for ongoing professional growth and development.

* Works with RATM Director to identify opportunities for project to move from bench to discovery to development and early-phase human testing

* Completes all hospital required and job related in-services and applies the information needed.

* Helps to ensure patient satisfaction, physician satisfaction and effective revenue cycle process.

This position description is not intended to be all inclusive, and the employee will also perform other reasonably related business duties as assigned by the immediate supervisor and other management as required. The Houston Methodist Hospital reserves the right to revise or change job duties and responsibilities as the need arises.


Bachelor's degree or 30 hours college coursework preferred


3 years relevant research program experience




* Attention to detail with a high priority for timely and accurate information.

* Ability to work independently, as well as on cross-functional and interdisciplinary teams.

* Strong time management/organizational skills are essential.

* Strong verbal and written communication skills.

* Strong analytical and interpersonal skills.

* Ability to work under pressure and balance many competing priorities.

* Proficient in spreadsheet, word-processing, and presentation software.

* Ability to interact with all members of the medical staff, healthcare team and leadership in a professional and courteous manner.

* Working knowledge of FDA regulations and GxP.

* Strong analytical skills.

* Document management skills.

* Advanced working knowledge of Microsoft Project, PowerPoint, etc.

Equal Employment Opportunity

Houston Methodist is an Equal Opportunity Employer.

Equal employment opportunity is a sound and just concept to which Houston Methodist is firmly bound. Houston Methodist will not engage in discrimination against or harassment of any person employed or seeking employment with Houston Methodist on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, status as a protected veteran or other characteristics protected by law.

VEVRAA Federal Contractor priority referral Protected Veterans requested.

Company Profile

Houston Methodist Research Institute was formed in 2004 to rapidly and efficiently translate discoveries made in the laboratory and the clinic into new diagnostics, therapies and treatments. The research institute was created to provide the infrastructure and support for these endeavors, and to house the technology and resources needed to make innovative breakthroughs in important areas of human disease. A 540,000 square foot building dedicated to research, the research institute houses over 1,500 staff and trainees, 277 principal investigators and has more than 840 ongoing clinical trials. APPLY.