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Research Protection Analyst

Company: Houston Methodist
Location: Houston
Posted on: February 23, 2021

Job Description:

Houston Methodist Academic Institute
1130 John Freeman St.
Houston, TX 77030
Category: Non-Clinical Research
Job Type: Full-Time Work Shift: DAYWork Week: M - F
Job Summary
At Houston Methodist, the Research Protection Analyst (IRB) is responsible for: Comprehensive analysis of human research studies for compliance with regulations, guidelines, and institutional policies. This includes the review of submissions for completeness and compliance with HMRI policy and Federal regulations; Gather additional data as necessary from researchers, study staff, and others; Provide education and training to researchers and IRB Members; Advise researchers of submission problems and suggest solutions; and Advise and provide input to IRB Chair and other stakeholders regarding regulation rules and intent, compliance and regulatory limits. May also be responsible for Business Practice Committee management and Conflict of Interest review.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 jobPRIMARY JOB RESPONSIBILITIESJob responsibilities labeled EF capture those duties that are essential functions of the job.PEOPLE -20%
          • Assists institutional investigators, regulatory and other members of the research team by providng education and training regarding IRB and / or COI requirements and the electronic submission process. This training can be ad hoc, or face to face sessions with the entire research team.
          • Communicates with related regulatory committees and administrative departments to assure efficient completion of required reviews, as well as communicating IRB requirements to the research team in writing and in person to assure understanding and appropriate response. SERVICE -20%
          • Participates in HM projects if applicable.
          • Assists other Research Protections staff as needed, including Quality Assurance, IBC, RSC, and HSC. QUALITY/SAFETY -45%
          • Coordinates all aspects of human research proposal submission, review, and approval process, and assures reviews are commensurate with funding agency and regulatory applicable regulations.
          • Conducts initial review of IRB applications to assure completeness, consistency and accuracy. This requires review of the protocol, informed consent and electronic application.
          • Makes an initial determination for required review; whether an application requires IRB review and what type of review is required. Provides IRB Chairs with synopsis and initial review for all applications including initial application, continuing reviews, reportable events and amendments. Responsible for review and correspondence for administrative (minor, minimal risk) amendments.
          • Reviews responses to IRB reviews; assuring that the response meets the IRb's concerns prior to forwarding the application to the reviewer or placing it on the agenda.
          • Prepares meeting agendas and assures quorum, along with drafting official IRB correspondence and IRB minutes.
          • Reviews requirements for other committees, conflict of interest and credentialing prior to final approval.
          • Primary responsibility for review of Conflict of Interest reports, as assigned. This includes: Serving as COI analyst and contact person for the department's COI related questions and issues. Coordinating the annual certification process for COI disclosures. Assist with reviewing procedures governing the disclosure, review, and management of COI. Serve as BPC analyst to coordinate Business Practice Committee meetings, set meeting calendar and arrange room and catering, record minutes. FINANCE -5%
          • Appropriately utilizes department resources such as time and equipment. GROWTH/INNOVATION -10%
          • 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 Director with achieving and maintaining human research protection accreditation. 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 REQUIREMENTS
            • Bachelors Degree in related field required.EXPERIENCE REQUIREMENTS
              • 3 years of related clinical research or commensurate experience required.CERTIFICATIONS, LICENSES AND REGISTRATIONS REQUIRED
                • Optional Certificates: Certified IRB Professional (CIP), other Clinical Research certificate.KNOWLEDGE, SKILLS AND ABILITIES REQUIRED
                  • 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
                    • --Must have ability to rapidly acquire and implement knowledge of related regulations and ethical principles.
                    • Position requires the exercise of independent judgment related to situations of a sensitive, confidential and scientific nature.SUPPLEMENTAL REQUIREMENTSPlease indicate the requirements of the job by selecting the appropriate response. Work Attire Yes/NoUniform NoScrubs No Business professional NoOther (dept approved) NoOn-Call* No (for Non-Exempt or Exempt jobs)*Note that employees may be required to be on-call during emergencies (ie. Disaster, Severe Weather Event, etc) regardless of selection above.Travel** May require travel within YesHouston Metropolitan areaMay require travel outside Yes of Houston Metropolitan area **Travel specifications may vary by department. Please note any other special considerations to this job: __________________________
                      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. Quality Assurance Analyst- Cancer Clinical Trials
                      Houston Methodist Academic Institute, Houston, TX
                      Work Shift: DAYWork Week: M - FJob SummaryAt Houston Methodist, the ACM Quality Assurance Analyst is responsible for working with specified oncology clinical research teams --- Graduate Research Fellow- Orthopedics
                      Houston Methodist Academic Institute, Houston, TX
                      Work Shift: DAYWork Week: M - FJob SummaryThis position is designed for educational and research experience for individuals working towards Masters or Doctoral degrees. The --- Research Protection Analyst
                      Houston Methodist Academic Institute, Houston, TX
                      Work Shift: DAYWork Week: M - FJob SummaryAt Houston Methodist, the Research Protection Analyst (IRB) is responsible for: Comprehensive analysis of human research studies for --- We are proud to announce both Houston Methodist Hospital and Houston Methodist Baytown Hospital are ranked top ICUs as part of Healthgrades' 2021 Specialty Excellence Awards. The awards look to recognize hospitals delivering superior patient outcomes across 16 service lines. 214 hospitals were featured on the critical care list for --- Houston Methodist is excited to announce our newest partnership with Amazon's Alexa. We are launching functionality to allow Nurses to find jobs at Houston Methodist via their Alexa app or device. Now, Nurses can join our world-class team from anywhere. We are always working to make job searching easy for --- Houston Methodist is honored to be recognized with two prestigious awards by Press Ganey in 2020: The Pinnacle of Excellence Award and the Guardian of Excellence Award.The Pinnacle of Excellence Award recognizes top-performing healthcare organizations for achieving and maintaining consistently high levels of excellence over three years in patient --- Houston Methodist - Our Awards Get Us Noticed, But Our People Make Us Stand Out. With your support, Houston Methodist provides exceptional research, education and care that is truly leading medicine.

Keywords: Houston Methodist, Houston , Research Protection Analyst, Professions , Houston, Texas

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