Research Compliance Specialist

Scheduled Hours

37.5

Position Summary

The Human Research Quality Assurance (HRQA) program monitors active research protocols to ensure the protection of human subjects and confirm that research is conducted in compliance with federal regulations and University policies. In addition, the program seeks to elevate the quality of the institutions research efforts by providing education and guidance to researchers and staff through feedback while on site and through the creation of educational programs offered to the research community at large. The Research Compliance Specialist will actively monitor research and provides high-level logistical and administrative programmatic support for research administration.

Job Description

Primary Duties and Responsibilities

• Monitors selected human research protocols for compliance with the IRB approved consent process.
• Prepares reports of monitoring activity for presentation (written and oral) to the faculty committee.
• Monitors management plans imposed by the Vice Chancellor for Research or other compliance committees in order to help the University meet its compliance responsibilities.
• Manages execution and logistics of educational programs provided by the HR QA program.
• Assists in developing and implementing research quality assurance compliance programs that assess risks, measures compliance program effectiveness and identifies opportunities for improvement as assigned.
• Works closely with other university administrative offices involved in the management of human research to coordinate a consistent and integrated approach to oversight of human research projects and the implementation of any necessary management and education plans.
• Develops and maintains a thorough knowledge of the regulations and University policies relating to human research, keeping up-to-date with new and revised regulatory policy to assist in modifying WU policies, educational programs and communication tools.
• Provides support to the HRQA Committee by 1) documenting and maintaining detailed case files including meeting minutes, committee actions, decisions, reports and correspondence; 2) reviewing documentation, scheduling meetings, compiling agendas, preparing and coordinating documents for meetings.
• Under the direction of the Manager and the QA Chair, develop appropriate communications with faculty and staff and other key administrative offices.
• Ensure content maintenance of the HRQA website and the clinical research website portions of the OVCR website.
• Assists in the development and maintenance of written procedures related to all aspects of the implementation of the quality assurance monitoring program.
• Develops and maintains a working knowledge of the programs and directives of the department.
• Researches complex relationships and transactions; monitors for compliance and identifies and investigates instances of non-compliance.
• Reviews and evaluates, with minimal supervision, faculty and non-faculty personal financial relationships related to research to determine the applicability of the University’s policies and whether it needs further review by the faculty committees.
• Provides advice and counsel to faculty, non-faculty, committee members regarding university’s policies and processes, and federal, state and sponsoring agency regulations.

Working Conditions

• Hybrid work model: @1234 Kingshighway/@ home remote.
• Comfortable and friendly office setting/partial work from home, with occasional pressure due to coordination of multiple responsibilities.
• Coordination of education events and other meetings will require regular travel among the University campuses.

Preferred Qualifications

• Previous experience in research administration, preferable in a research intensive university, hospital or institute.
• Demonstrated understanding of a regulatory environment and ability to interpret regulations and policy.
• Demonstrated ability to work independently, identify and deal with potential problems proactively, and exercise good judgment.
• Strong organizational, prioritization, and communication skills are essential.
• Ability to make progress on both long and short term goals while responding to frequent interruptions.
• Demonstrated ability to manage confidential information.
• Ability to prioritize tasks for multiple long and short term projects.
• Ability to work successfully within a team environment.
• Excellent grammar, a critical eye, and attention to detail are all imperative.
• Interaction with faculty and administrative support of senior University management requires a friendly, positive attitude, excellent customer service skills, and a high degree of professionalism.
• Ability to effectively accumulate and organize data for reporting.
• Adept knowledge of computers and common software programs (e.g., Word, Excel, and PowerPoint).

Required Qualifications

Bachelor's degree or five years of comparable work experience.

Grade

G09

Salary Range

$45,600.00 - $75,300.00 / AnnuallyThe salary range reflects base salaries paid for positions in a given job grade across the University. Individual rates within the range will be determined by factors including one's qualifications and performance, equity with others in the department, market rates for positions within 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 CandidateQuestions@wustl.edu or call the dedicated accommodation inquiry number at 314-935-1149 and leave a voicemail with the nature of your request.

Pre-Employment Screening

All 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 check 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. All 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 priority appointments and lower copays/coinsurance.
• Want to Live Near Your Work and/or improve your commute? Take advantage of our free Metro transit U-Pass for eligible employees. We also offer a forgivable home loan of up to $12,500 for closing costs and a down payment for homes in eligible neighborhoods.
• 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, mental health resources, 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 continued 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: [https://hr.wustl.edu/benefits/>

EEO/AA Statement

Washington University in St. Louis 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 all job titles without regard to race, ethnicity, color, national origin, age, religion, sex, sexual orientation, gender identity or expression, disability, protected veteran status, or genetic information.

Diversity Statement

Washington University is dedicated to building a diverse community of individuals who are committed to contributing to an inclusive environment – fostering respect for all and welcoming individuals from diverse backgrounds, experiences and perspectives. Individuals with a commitment to these values are encouraged to apply.