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JOB SUMMARYAt Houston Methodist, the IRB Regulatory Reviewer position is responsible for performing extensive reviews of biomedical and behavioral human subject research using independent judgment and knowledge of regulations to meet and exceed objectives while contributing to the Houston Methodist Research Institute (HMRI’s) overall mission to protect the rights and welfare of human subjects involved in research. This position enhances the quality of protocols that are submitted to the convened IRB for review, and the expedited IRB review process. The IRB Regulatory Reviewer position is an expert in human subject research regulations as demonstrated by their level of engagement specifically in an Institutional Review Board (IRB) office. This position requires advanced working knowledge of the federal, state, and international laws, regulations, and guidance and the ability to interpret and apply these regulations to both clinical and non-clinical research projects. The IRB Regulatory Reviewer position will act as a member of the HMRI IRB as designated by the HMRI IRB Chair and may also make determinations of not human subjects research, serving as an expedited reviewer for exempt research and minor modifications to ongoing research. This position partners with experts which may include physician-scientists or other clinical/research professionals, Office of Research Protections (ORP) colleagues and scientists in the social-behavioral-educational sciences, or ORP and Institutional colleagues in research administration.PATIENT AGE GROUP(S) AND POPULATION(S) SERVEDRefer to departmental "Scope of Service" and "Provision of Care" plans, as applicable, for description of primary age groups and populations served by this job for the respective HM entity.HOUSTON METHODIST EXPERIENCE EXPECTATIONS
Provide personalized care and service by consistently demonstrating our I CARE values:
INTEGRITY: We are honest and ethical in all we say and do.
COMPASSION: We embrace the whole person including emotional, ethical, physical, and spiritual needs.
ACCOUNTABILITY: We hold ourselves accountable for all our actions.
RESPECT: We treat every individual as a person of worth, dignity, and value.
EXCELLENCE: We strive to be the best at what we do and a model for others to emulate.
Focuses on patient/customer safety
Delivers personalized service using HM Service Standards
Provides for exceptional patient/customer experiences by following our Standards of Practice of always using Positive Language (AIDET, Managing Up, Key Words)
Intentionally rounds with patients/customers to ensure their needs are being met
Involves patients (customers) in shift/handoff reports by enabling their participation in their plan of care as applicable to the given job
Displays cultural humility, diversity, equity and inclusion principles
Actively supports the organization vision, fulfills the mission and abides by the I CARE values
PRIMARY JOB RESPONSIBILITIESJob responsibilities labeled EF capture those duties that are essential functions of the job.PEOPLE - 20%
Serves as an expert in human subject research regulations. Collaborates with other experts to perform and conduct informed, qualitative review of biomedical and behavioral research involving human participants, using independent judgment and knowledge of regulations. (EF)
Partners with the research community to provide guidance and consultation to investigators and research personnel to ensure research meets the requirements of the regulations governing human subjects research and the HMRI IRB policies and procedures.
Acts as a member of the HMRI IRB, as designated by the HMRI IRB Chair. May also make determinations of non-human subjects research, serving as an expedited reviewer for exempt research and minor modifications to ongoing research. Attends IRB meetings and acts as voting member, as needed. (EF)
Serves as resource for IRB staff and members. Develops and participates in training and educational activities on human research. Drives contributions towards improvement of department scores for employee engagement, i.e., peer-to-peer accountability. (EF)
SERVICE - 30%
Guides the research teams on the changes needed to research protocols in order to meet the regulatory requirements for IRB review and secures IRB approval of submitted protocols. (EF)
Makes determinations of not human subjects’ research. Serves as an expedited reviewer for exempt research and minor modifications to ongoing research. (EF)
Composes correspondence to investigators articulating modifications required in the research to secure IRB approval and any questions, concerns, or clarifications that need to be addressed before IRB approval can be considered. (EF)
Assists with review, investigation and reporting of reportable new information incidents and may present these incidents to the convened board. (EF)
QUALITY/SAFETY - 25%
Enhances the quality of protocols that are submitted to the convened IRB for review, and the expedited IRB review process. (EF)
Manages submissions in the IRB electronic system to ensure compliance with regulations for reporting and documentation, and timely reviews of IRB. Interfaces with Research Technology to optimize electronic submission process. (EF)
Adheres to turnaround times for review and processing activities; identify opportunities for improvement; participates in process improvement activities; implements requested changes. (EF)
Provides specialized administrative support, regulatory compliance review and management of specific regulatory committees and in preparation for accreditation and in various compliance and quality assurance activities. (EF)
FINANCE - 10%
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. (EF)
GROWTH/INNOVATION - 15%
Maintains a working knowledge of current regulations, guidelines, and trends influencing the conduct of human subject research. (EF)
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. (EF)
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 REQUIREMENTSo Bachelor’s degree in business administration or scientific discipline/life sciences or relevant fieldo Master’s degree, Ph.D. or other advanced degree in scientific discipline/life sciences or related field preferredEXPERIENCE REQUIREMENTSo Five years of extensive, independent IRB experienceo Previously served as an IRB expedited reviewerCERTIFICATIONS, LICENSES AND REGISTRATIONS REQUIREDo Certified IRB Professional (CIP)KNOWLEDGE, SKILLS AND ABILITIES REQUIREDo Demonstrates the skills and competencies necessary to safely perform the assigned job, determined through on-going skills, competency assessments, and performance evaluationso 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 securityo Ability to effectively communicate through a variety of channels with patients, physicians, family members and co-workers in a manner consistent with a customer service focus and application of positive language principles; engages the recipient(s) and helps them understand and retain the messageo Advanced working knowledge of the federal, state, and international laws, regulations, and guidance, including US Good Clinical Practice (GCP), Code of Federal Regulations (CFR) Titles 21 and 45, and International Conference on Harmonization (ICH) Guidelines, and the Association for Accreditation Human Research Protection Programs (AAHRPP) standardso Strong knowledge of Microsoft Office products (Word, Excel, PowerPoint, and Outlook)o Working knowledge of a significant body of scientific and medical concepts and terminologyo Ability to investigate and analyze scientific topics on the internet and in scientific journalso Comfortable making independent decisions within a designated frameworko Detail-oriented, including auditing skillso Ability to manage several projects at onceo Conceptual thinking and the ability to apply knowledge to a variety of situationso Excellent communication skills, written and oral, including public speakingo Ability to analyze regulations and guidance’s and apply to written research protocolso Ability to critically read research proposals and determine adherence to regulatory criteria and institutional policyo Demonstrated understanding of the principles of human research protection standardsSUPPLEMENTAL REQUIREMENTSWork Attire Yes/NoUniform NoScrubs YesBusiness professional YesOther (dept approved) NoOn-Call NoNote that employees may be required to be on-call during emergencies (i.e., Disaster, Severe Weather Event, etc.) regardless of selection aboveTravelMay require travel within NoHouston Metropolitan areaMay require travel outside Noof Houston Metropolitan areaTravel specifications may vary by department.Please note any other special considerations to this job: office or laboratory environmentHouston 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, 284 principal investigators and has more than 570 ongoing clinical trials.Street: 7550 Greenbriar Drive Name: HRPO - IRB Regular Shift: 1st - Day
