At Houston Methodist, the Sr Human Research Protection (HRP) Analyst position is responsible for regulatory compliance that supports the Human Research Protections Office (HRPO) and the Institutional Review Boards (IRB). This position completes the comprehensive analysis of clinical research protocols and associated submissions for completeness, consistency, and compliance with regulations, guidelines, and institutional policies in preparation for IRB review. The Sr. HRP Analyst position serves as a primary point of contact for research stakeholders as a subject-matter expert in support of the Human Research Protections Office (HRPO) and the IRB's day-to-day operations. This position is solution-oriented and provides outstanding, consistent customer service and will mentor lower-level team members, including HRP Analysts and HRP Coordinators. The Sr. HRP Analyst position participates as needed in structured education and training sessions for research stakeholders and provides support to Office of Research Protections (ORP) leadership in the administrative management of the HM Business Practice Committee (BPC), including agenda management, scheduling meetings, and taking and preparing meeting minutes. The Sr. HRP Analyst position may also provide support in the management of Conflict of Interest (COI) reviews.

　　PEOPLE ESSENTIAL FUNCTIONS

　　Serves as a team lead for HRP Analysts and HRP Coordinators, assisting in their professional development by providing guidance on HRPO processes and workflows, institutional policy and federal and state regulatory requirements.

　　Participates in educational workshops for individuals engaged in research at the institution. Assists institutional investigators, regulatory and other members of the research team by providing education and training regarding HRPO and IRB requirements.

　　Provides expert consultation and guidance to on an ongoing basis. Communicates with related regulatory committees and administrative departments to assure efficient completion of required reviews. Provides education and training in a structured manner to IRB members on an ongoing basis annually.

　　Role models' healthy work relationships such as mitigation of conflict, leading problem-solving and resolution efforts. Provide outstanding, consistent customer service which includes written and verbal communication with stakeholders and colleagues.

　　Conducts self in a manner that is congruent with cultural diversity, equity, and inclusion principles. Initiates contributions towards improvement of department scores for employee engagement, i.e., peer-to-peer accountability.

　　SERVICE ESSENTIAL FUNCTIONS

　　Provides administrative support to the BPC administrator including scheduling meetings, meeting location arrangements, catering when applicable, and generation of meeting minutes. Serves as a project lead for department/institutional initiatives, upon request.

　　Reviews official IRB correspondence and minutes drafted by HRP Coordinators and HRP Analysts to ensure IRB reviews are accurately captured.

　　QUALITY/SAFETY ESSENTIAL FUNCTIONS

　　Consistently evaluates process and workflow to ensure efficiency and compliance in the facilitation of research across the health system and communicates effectively with ORP leadership any gaps or areas for improvement.

　　Leads the administrative process in support of IRB review and determinations. Conducts thorough and complete regulatory review of IRB applications to assure completeness, consistency, and accuracy. Ensures accurate and timely processing, tracking, and filing of submissions and documentation of IRB actions.

　　Triages protocol submissions to determine the appropriateness of IRB review. Determines correct level of regulatory IRB review required based on HHS and FDA regulations. Provides IRB members with synopsis and regulatory guidance for all applications, from initial review through study closure.

　　Attends IRB meeting to serve as the regulatory subject matter expert, advising IRB Members and other HRPO team members in management of IRB meetings and adherence to regulatory requirements.

　　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

　　Identifies areas of the review process that require improvement, or that could be made more efficient and effective. Works with the electronic submission team to resolve problems, suggest improvements and test programming upgrades.

　　Assists leadership in human research protection (re)accreditation processes.

　　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 within a related field

　　Master's degree in Research Administration, Legal, Ethics, Policy, or related field preferred

　　WORK EXPERIENCE

　　Five years of related work experience OR Master's degree with three years of related work experienceLICENSES AND CERTIFICATIONS - REQUIRED

　　CIRB - Certified International Review Board (IRB) Professional (PRMR)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

　　Ability to rapidly acquire and implement knowledge of related regulations and ethical principles

　　Exercise independent judgment related to situations of a sensitive, confidential, and scientific nature

　　Strong project management skills

　　Ability to initiate and complete tasks with minimal supervision

　　Ability to deal with high volumes and rigid deadlines

　　Ability to maintain effective interpersonal relationships

　　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 Yes

　　May require travel outside Houston Metropolitan area Yes

　　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.