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The primary function of the Quality Assurance Analyst is to support the Institutional Review Board (IRB) and the Conflict of Interest Office (COI) at the University of Maryland College Park (UMCP). The IRB is responsible for the confidential review and approval of UMCP human subject research. The COI Office is responsible for the processing of approved management plans which mitigate or eliminate perceived or actual conflicts in research. The University of Maryland College Park adheres to the principles of the Belmont Report and assures full compliance with all federal regulations, state laws, and university policies governing conflict of interest and the human subjects research.
A secondary function of the QA Analyst is to support the Export Compliance Office (ECO). The ECO supports research in areas subject to US export control laws including the International Traffic in Arms Regulations (ITAR), the Export Administration Regulations (EAR), and the Office of Foreign Asset Control (OFAC) sanctions regulations. For research that is subject to export compliance regulations, the Export Compliance Officer works with researchers to create a Technology Control Plan (TCP) which establishes the security controls that will be utilized to protect the sensitive research and ensure compliance with the laws. The QA Analyst will support the Export Compliance Office by carrying out post approval monitoring requirements established in the TCP including, but not limited to, follow-up visits, inspections, audits, and debriefing of the researchers.
The Quality Assurance program is an objective, systematic way in which the University can assure research sponsors and federal agencies that human subject research at UMCP is compliant with applicable federal and state regulations, UMCP policies, and the IRB Approved project, and thereby protects the safety and welfare of human participants. The UM Quality Assurance program will be educational rather than punitive in approach.
The Quality Assurance Analyst will assess how research is conducted and how research records and documentation are kept; provide researchers and research staff with training and assistance following assessments to help address any identified deficiencies; report findings and outcomes to the IRBs, HRPP management, and the Vice President for Research. The Quality Assurance Analyst must frequently and efficiently address complex compliance issues requiring a sophisticated knowledge and application of ethical principles, regulations, research, and the University. The UMCP IRB reviews social/behavioral research as well as biomedical research. Quality Assurance monitoring activities are likely to focus on biomedical research because of the increased regulatory complexity and physical risks to subjects in such research.
Bachelor’s Degree in a health-related or social-behavioral field.
At least three years of administrative experience in a medical, health care, educational, research or academic setting. At least two years of experience working in human subject or managing research with one year of direct experience reviewing human subject research.
Knowledge of, and experience with, applying federal human subject regulations, including analysis and making decisions about imprecise regulations or ambiguous situations.
Experience working cooperatively and collaboratively with others in challenging situations. Experience delivering training or education in a 1:1 or small-group setting.?
Strong interpersonal and communication skills (written and verbal); ability to provide and explain detailed reports; and the ability to interact with multiple levels of staff and customers in a variety of contexts in a tactful, non-confrontational manner.
Ability to handle sensitive matters with discretion, tact, and confidentiality. Strong consultative skills with the confidence and ability to enforce rules.
Computer literacy with standard word processing, MS Office Suite (i.e., Excel, Word, PowerPoint), email, and Internet applications.
An advanced degree is preferred. Experience in a large college, university, or other research institution. Experience conducting research as a researcher or member of a research team. Export compliance, physical security, and IT security experience will also be considered favorably.
Candidates must be able to provide proof of eligibility to work in the USA. No Visa sponsorship is offered for this position.
Posting Number: E0006151
Posting Date: 03/07/2017
Open Until Filled: Yes
Best Consideration Date: 03/28/2017
How to apply: All interested applicants must apply online through ejobs.umd.edu (https://ejobs.umd.edu/postings/50085 ).
Sedentary work performed in a normal office environment, but must be able to conduct on-site audits and training sessions at locations throughout campus and off-campus locations. Some travel to professional meetings and conferences both on and off campus.
The University of Maryland, College Park, an equal opportunity/affirmative action employer, complies with all applicable federal and state laws and regulations regarding nondiscrimination and affirmative action; all qualified applicants will receive consideration for employment. The University is committed to a policy of equal opportunity for all persons and does not discriminate on the basis of race, color, religion, sex, national origin, physical or mental disability, protected veteran status, age, gender identity or expression, sexual orientation, creed, marital status, political affiliation, personal appearance, or on the basis of rights secured by the First Amendment, in all aspects of employment, educational programs and activities, and admissions.
Founded in 1856, University of Maryland, College Park is the flagship institution in the University System of Maryland. Our 1,250-acre College Park campus is just minutes away from Washington, D.C., and the nexus of the nation’s legislative, executive, and judicial centers of power. This unique proximity to business and technology leaders, federal departments and agencies, and a myriad of research... entities, embassies, think tanks, cultural centers, and non-profit organizations is simply unparalleled. Synergistic opportunities for our faculty and students abound and are virtually limitless in the nation’s capital and surrounding areas. The University is committed to attracting and retaining outstanding and diverse faculty and staff that will enhance our stature of preeminence in our three missions of teaching, scholarship, and full engagement in our community, the state of Maryland, and in the world.