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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 or external 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 for Department of Medicine will also work with industry sponsors’ or grant funder’s regulatory personnel for study regulatory start up and study regulatory maintenance throughout the study. This position communicates closely with the study teams including research coordinators, clinical trial managers, and principal investigators, sponsor partners, IRB staff, and regulatory office staff. Attention to detail, ability to navigate multiple projects and good time management are important in the success of this position. 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 needed

GROWTH/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 experience

LICENSES 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* No

TRAVEL

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:

Houston Methodist Academic Institute oversees the Education Institute and Research Institute, including 772 faculty and 56,250 learners. The Academic Institute aligns our research and education initiatives in service to the clinical mission, providing solutions that answer the call for new technologies and skills our clinicians need for patient care.

Houston Methodist Education Institute coordinates our primary academic affiliation with Weill Cornell Medicine and other joint programs, including the Engineering Medicine Program at Texas A&M University Intercollegiate School of Engineering Medicine. The Education Institute also oversees continuing medical education and graduate medical education, and supports more than 1,000 trainees in residence for medical, nursing, allied health and research education programs.

Houston Methodist Research Institute supports research programs and infrastructure that enable faculty across the system to bring new scientific discoveries to patients as rapidly as possible through the full cycle of a cure from conceptual bench research, to prototyping and development, to clinical trials and FDA approval. The Research Institute supports more than 1,387 clinical research protocols and $70.3 million in extramurally funded translational research programs.

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.