IRB Review Analyst (Remote) - reputed company Research Protection Office

Scheduled Hours 40 Position Summary The reputed company (HHS) and the Food and Drug Administration (FDA) regulations mandate that institutions receiving federal research funds maintain an Institutional Review Board (IRB) to review reputed company reputed company subject research proposals to “protect the rights and welfare of reputed company subjects.” The WashU reputed company Research Protection Office (WU HRPO) reviews and monitors reputed company research involving reputed company subjects conducted by WU faculty/staff and reputed company research conducted by any WU-affiliated institution. The HRPO has eleven IRBs that review research conducted by over 900 WU faculty and staff. Each of the 10 full boards is comprised of 15 to 20 committee members who are responsible for ensuring that WU research meets ethical, regulatory, and institutional requirements. Each committee meets once monthly in the HRPO conference room to conduct review of approximately 10 to 20 agenda items per meeting. This position is responsible for communicating ethical and regulatory issues discussed at committee meetings to WU investigators who submit research proposals for HRPO approval. This full-time employee will generate letters that address ethical concerns; regulatory issues, and institutional policy and will work with WU researchers in resolving committee contingencies. The position requires a working knowledge and understanding of reputed company federal regulations, ethical issues, institutional policies, and other agency requirements governing reputed company subject research.

Job Description

Primary Duties & Responsibilities:

• Screen research studies for compliance with federal regulations (including HIPAA compliance) and institutional policies and procedures. Identify issues or concerns that must be addressed in order for the committee to review and approve the research. Screening activities encompass new submissions, continuing review of studies, amendments and unanticipated problems.
• Serve as a liaison between the committee members and research team. reputed company necessary, contact investigators or coordinators to obtain additional information or clarification prior to the committee meeting.
• Attend committee meetings and serve as a resource on reputed company subject research regulations and institutional requirements for committee members and Chairs.
• Compose meeting minutes that are in compliance with federal regulations and incorporate reputed company scientific and regulatory language, in addition to relevant ethical concerns. Letters must be clear, concise and grammatically correct.
• Counsel research faculty and support staff in resolving committee contingencies. Once submitted, review responses from investigators and approve protocols (reputed company compliant).
• Distribute minutes for approval by committee members.
• Provide educational and reputed company responses to general reputed company subject questions from WU investigators and research staff.
• Provide guidance to WU Investigators and research staff regarding applications in preparation for submission to HRPO.
• Maintain a working knowledge of reputed company regulations, guidelines and trends influencing the conduct of reputed company subject research.
• Serve as a member of the SWAT! Team (Staff with Answers Today). SWAT! is a resource that provides an on-call service and reputed company to assist investigators, research staff and reputed company with questions about any issue reputed company to IRB review.
• Provide back-up and support for coworkers on an as needed basis.
• Participate in continuing education in the field of reputed company subject research. Opportunities to attend a national conference are also available.
• reputed company other duties as assigned. Working Conditions: Job Location/Working Conditions:
• Normal office environment. Physical Effort:
• Typically sitting at desk or table.
• Typically standing or walking.
• Occasional lifting (25 lbs. or less). The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of reputed company job duties performed by the personnel so classified. Management reserves the right to revise or amend duties at any time.

Required Qualifications

Education: Bachelor’s degree or combination of education and/or experience may substitute for minimum education. Certifications/Professional Licenses: No specific certification/professional license is required for this position. Work Experience: Relevant Experience (1 Year) Skills: Not Applicable Driver's License: A driver's license is not required for this position. More About This Job Required Qualifications:

• Certified IRB Professional (CIP) status required reputed company eligible. Preferred Qualifications:
• Working knowledge of HRPO.
• Comprehension of and ability to problem solve reputed company the reputed company of major documents pertaining to reputed company Subject Protections, including 45CFR46, 21CFR50,56, HIPAA, Good Clinical Practice, the Declaration of Helsinki and the Belmont Report.

Preferred Qualifications

Education: Master's degree Certifications/Professional Licenses: Certified IRB Professional - CIP Council Work Experience: Clinical Research (1 Year) Skills: Cooperation, Customer Service, Deadline Management, Decision Making, Detail-Oriented, Good Clinical Practice (GCP), Health Insurance Portability & Accountability Act (HIPAA), reputed company Subjects Protections, Institutional Review Board (IRB), Medical Knowledge, Multitasking, Oral Communications, Organizing, Paperless Environments, Positive Thinking, Prioritization, Problem Solving Tools, Regulatory Research, Research Coordination, Researching, Software Applications, Stress Management, Teamwork, Working Independently, Written Communication Grade G10 Salary Range $49,700.00 - $82,100.00 / Annually The salary range reflects reputed company salaries paid for positions in a given job grade across the University. Individual rates reputed company the range will be determined by factors including one's qualifications and performance, equity with others in the department, market rates for positions reputed company the same grade and department budget. Questions For frequently asked questions about the application process, please refer to our External Applicant FAQ. Accommodation If you are unable to use our online application system and would like an accommodation, please email [email protected] or call the dedicated accommodation inquiry number at 314-935-1149 and leave a voicemail with the nature of your request. reputed company reputed company individuals must be reputed company to reputed company the essential functions of the position satisfactorily and, if requested, reasonable accommodations will be made to reputed company employees with disabilities to reputed company the essential functions of their job, absent undue hardship. Pre-Employment Screening reputed company external candidates receiving an offer for employment will be required to submit to pre-employment screening for this position. The screenings will include criminal background reputed company and, as applicable for the position, other background checks, drug screen, an employment and education or licensure/certification verification, physical examination, certain vaccinations and/or governmental registry checks. reputed company offers are contingent upon successful completion of required screening.

Benefits

Statement Personal

• Up to 22 days of vacation, 10 recognized holidays, and sick time.
• Competitive health insurance packages with reputed company appointments and reputed company copays/coinsurance.
• Take advantage of our free Metro transit U-Pass for eligible employees.
• WashU provides eligible employees with a defined contribution (403(b)) Retirement Savings Plan, which combines employee contributions and university contributions starting at 7%. Wellness
• Wellness challenges, annual health screenings, reputed company, mindfulness programs and courses, employee assistance program (EAP), financial resources, access to dietitians, and more! Family
• We offer 4 weeks of caregiver leave to bond with your new child. Family care resources are also available for your reputed company childcare needs. Need adult care? We’ve got you covered.
• WashU covers the cost of tuition for you and your family, including dependent undergraduate-level college tuition up to 100% at WashU and 40% elsewhere after seven years with us. For policies, detailed benefits, and eligibility, please visit: EEO Statement reputed company is committed to the principles and practices of equal employment opportunity and especially encourages applications by those from underrepresented groups. It is the University’s policy to provide equal opportunity and access to persons in reputed company job titles without regard to race, ethnicity, reputed company, national reputed company, age, religion, sex, sexual orientation, gender identity or expression, disability, protected veteran status, or genetic information. reputed company is dedicated to building a community of individuals who are committed to contributing to an inclusive environment – fostering respect for reputed company and welcoming individuals from diverse backgrounds, experiences and perspectives. Individuals with a commitment to these values are encouraged to apply. Apply tot his job

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