At Houston Methodist, the Senior (Sr.) Regulatory Compliance Specialist position is responsible for 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). 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 Sr Regulatory Compliance Specialist position maintains documentation for clinical research studies, case report forms and study and regulatory files. Under minimal supervision from the Manager or Director, this position identifies problem-solving issues of moderate to complex scope. The Sr Regulatory Compliance Specialist position contributes directly to internal departmental monitoring and research education as identified by the Manager or Director.

　　PEOPLE ESSENTIAL FUNCTIONS

　　Collaborates with cross-functional teams including key study personnel. Role models strong, positive communication skills to ensure cohesive, smooth operation of the department

　　Assists in training regulatory personnel and others on regulatory and safety reporting regulations, processes, and procedures under the direct supervision of the Regulatory Compliance Manager (serves as a resource for regulatory information and guidance)

　　Develops and maintains interpersonal relationships with a wide variety of healthcare professionals and hospital leadership. Maintains credibility with IRB and other regulatory agencies, Sponsors, vendors, patients, and co-workers

　　Role models behaviors that are congruent with cultural diversity, equity, and inclusion principles. Initiate's improvement recommendations for department scores for employee engagement, i.e., peer-to-peer accountability

　　SERVICE ESSENTIAL FUNCTIONS

　　Serves as subject matter expert in support of department functions. Defines problems, collects data, establishes facts, and draws valid conclusions and evidence-based performance improvement via measurable results

　　Prepare and manage documents required to initiate investigational drugs trials. Prepares research protocols for IRB submission, submits protocol amendments, prepares renewals and necessary regulatory documents for submission to study sponsors. Submits adverse event reports, safety reports, and notifies IRB of study closures

　　Interfaces as needed with appropriate governmental agency on project/products as identified by the Manager. Assists in the preparation of periodic reports for FDA

　　Develops appropriate regulatory reports and associated documentation in accordance with SOPs and study specific processes under the direct supervision of the Regulatory Compliance Manager

　　QUALITY/SAFETY ESSENTIAL FUNCTIONS

　　Ensures compliance of general and study-specific regulatory and/or safety-related processes with SOP's, FDA, GCP, NIH and applicable regulations. Provide routine updates and reporting to the Regulatory Compliance Manager to ensure timely communication regarding status of regulatory and/or important safety related issues

　　Conducts internal reviews and audits to ensure compliance of regulatory forms and associated documentation

　　Serves 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

　　FINANCE ESSENTIAL FUNCTIONS

　　Utilizes resources with cost effectiveness and value creation in mind. Self-motivated to independently manage time effectively and prioritize daily tasks, assisting coworkers as neededGROWTH/INNOVATION ESSENTIAL FUNCTIONS

　　Seeks opportunities to identify self-development needs and takes appropriate action. Ensures own career discussions occur with appropriate management. Completes and updates the My Development Plan on an on-going basis.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.

　　EDUCATION

　　Bachelor's degree or higher

　　Master's degree preferred

　　WORK EXPERIENCE

　　Five years of experience in relevant research program experienceLICENSES AND CERTIFICATIONS - REQUIRED

　　RAC - Regulatory Affairs Certifications (RAPS) or

　　CCRC - Certified Clinical Research Coordinator (ACRP) or

　　CCRP - Certified Clinical Research Professional (SOCRA)

　　KNOWLEDGE, SKILLS, AND ABILITIES

　　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

　　SUPPLEMENTAL REQUIREMENTS

　　WORK ATTIRE

　　Uniform No

　　Scrubs No

　　Business professional Yes

　　Other (department approved) No

　　ON-CALL*

　　*Note that employees may be required to be on-call during emergencies (ie. DIsaster, Severe Weather Events, etc) regardless of selection below.

　　On Call* NoTRAVEL

　　Travel specifications may vary by department

　　May require travel within the Houston Metropolitan area No

　　May require travel outside Houston Metropolitan area No

　　Company Profile:

　　The Houston Methodist Academic Institute team science approach bridges the boundaries between medical specialties and research and development labs to advance the practice of medicine and population health. We innovate in health care delivery and technology by streamlining the path discoveries take into the clinic with inventive development and adoption practices. Our teams are also dedicated to training clinicians and researchers from around the world in translational medicine and advanced technology. Houston Methodist's primary academic affiliates are top-ranked Weill Cornell Medical College and the Weill Cornell Graduate School of Medical Sciences for faculty appointments and graduate programs offered on our Houston campus.

　　The Institute oversees 600,000 sq ft of dedicated space and the administrative and operational infrastructure for basic and applied research and clinical trials, including more than 20 advanced tech core facilities, extramural funding management, regulatory and legal strategy and compliance, and product development and commercialization. This infrastructure is fully integrated with our hospital systems and supports more than 50,000 learners, 700 faculty, 2000 credentialed researchers, 6,000 research projects and clinical trials that creates innovative breakthroughs in human disease and the practice of medicine every day.

　　Houston Methodist is an equal opportunity employer inclusive of women, minorities, disabled persons and veterans.

　　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.

　　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.