Requisition Number: RESEA02635
The Research Compliance Specialist will be responsible for developing, maintaining, and/or enhancing research compliance programs for the Glendale, AZ campus and will report to the Associate Director, Office of Research & Sponsored Programs (ORSP). The position will assist with federal and state regulation compliance governing research and will work closely with the university’s Biosafety Committee (BSC). The Research Compliance Specialist will serve as a resource to assist faculty and staff in the day-to-day operations of research-related activities, to ensure those activities are accomplished in a compliant manner.
Essential Duties and Responsibilities
- Identifies compliance issues and establishes procedures that foster research performance compliant with federal regulations, state laws and internal policies.
- Assists with the development, implementation, maintenance, and/or enhancement of a wide variety of research compliance issues, including:
- Liaise with the Director of Occupational Health and Safety as it relates to the Hepatitis B Program to ensure compliance with OSHA Bloodborne Pathogens Standard for research labs, where applicable.
- Annual Laboratory registrations
- Time and Effort Reporting
- Responsible Conduct of Research
- Import and Export Controls
- Compliance with NIH, NSF, OSHA, EPA, etc. regulations and guidelines related to research
- Provides administrative support for BSC and works closely with the Committee Chair to review and process protocols involving hazardous biological materials or chemicals.
- Enhances MWU’s biosafety program by working with research faculty to ensure the use of hazardous materials in each research lab are approved by the BSC, proper signage is posted, chemical inventories/ebinders are maintained and current on Material Safety Data Sheets (MSDS) Online, tracks biosafety levels applicable to each lab appropriate to their specific risk levels;
- Assists faculty and works closely with the BSC Chair to ensure research involving recombinant or synthetic nucleic acid molecules (rsNA) are submitted to the IBC for review and approval.
- Enhances MWU’s radiation safety program by overseeing the performance of swipe testing, radiation badge monitoring, etc. in the event radioisotopes are used on the Glendale campus;
- Enhances MWU’s research safety programs by ensuring campus safety manuals, e.g. Lab Safety Manual, Bloodborne Pathogens Exposure Control Plan, Chemical Hygiene Plan, Radiation Safety Handbook, etc. are maintained and accessible to researchers.
- Liaise with the Research Administrator on Institutional Animal Care and Use Committee (IACUC) and Institutional Review Board (IRB) studies that involve a biosafety or chemical safety component requiring review by the Biosafety Committee to facilitate concurrent reviews.
- Plans and assists with research laboratory inspections.
- Assists in the development and tracking of resesarch compliance education and training for all research faculty, staff and students to comply with laboratory safety training requirements.
- Approves research laboratory access once all lab safety training requirements have been completed.
- Coordinates Time and Effort reporting for federally funded grants in conjunction with Business Services.
- Assists the Associate Director of ORSP with oversight and coordination of intramural grant proposals, e.g. Faculty Seed Grant, One Health Grant, and Improving Health Care Delivery Grants.
- Improves MWU’s effort reporting for grants by documenting training for all who sign off on effort reports, and by tracking effort reports for all grant recipients, such that all effort reports are turned in and filled out appropriately and on time;
- Develops and supports effective lines of communication and advocacy which promote the reporting of research compliance concerns, to ensure that all of MWU’s research compliance programs have adequate financial and physical resources to perform the functions assigned to them;
- Ensures that compliance issues are handled in a timely and appropriate manner;
- Ensures that regulatory and policy updates are disseminated to investigators and research staff in a timely manner, performs ongoing monitoring of research compliance areas, acts decisively with recommendations on how to handle concerns about potential non-compliance, and provides reports on monitoring activities to the Associate Director of ORSP;
- Actively seeks current compliance information and make recommendations for required changes to MWU’s programs as needed.
- Oversees emergency and scheduled usage of the ORSP backup freezer;
- Develops and maintains a comprehensive Responsible Conduct of Research training (RCR) program that meets the requirements for National Institutes of Health (NIH) and National Science Foundation (NSF) trainees. Informs faculty of RCR training program and requirements to assure training delivery;
- Liaises with the Director of Occupational Health and Safety to facilitate researchers into the Respiratory Protection Program, and Hepatitis B Program, as needed.
- Enhances MWU’s export and import controls through tracking required training for faculty and staff shipping biological materials;
- Works with the BSC Chair, Director of Occupational Health and Safety, and Risk Management to establish and/or maintain prudent practices that comply with regulations regarding research-related: accident reviews, training/education, injury and illness records, waste management, and related record-keeping;
- Works with appropriate college representatives and research faculty to ensure that research-related biological, and chemical hazardous waste, sharps, and radioactive waste are each disposed of in a manner compliant with applicable regulations. Assists with development and implementation of the best service-oriented manner to incorporate compliance-related activities at MWU’s Glendale campus.
- Assists with other research-related assignments, as instructed by the ORSP Associate Director or Assistant Vice President of Research.
- Other duties as assigned by the Associate Director of ORSP.
This job has no supervisory responsibilities.
To perform this job successfully, an individual must be organized, a good communicator, possess strong record-keeping skills, and able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. This individual must be able to work in a constant state of alertness and safe manner and have regular, predictable, in-person attendance. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education and/or Experience
A Bachelor’s degree is required. Must have a minimum of 3 years of experience related to research administration or research compliance. Must have excellent verbal and written communication skills with the ability to advance multiple compliance projects simultaneously. Previous experience with Occupational Health and Safety, Respiratory Protection, Responsible Conduct of Research training, Biosafety, Time and Effort Reporting and Export Controls is preferred. Previous experience in the interpretation of regulations, policies, procedures, and ethical principles in research compliance is preferred. Must have the ability to develop regulations into operational policies and procedures.
Computer proficiency in MS Office (Word, Excel, Outlook).
Intermediate skills: Ability to read and interpret documents such as safety rules, operating and maintenance instructions and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization.
Intermediate skills: Ability to apply common sense understanding to carry out instructions furnished in written, oral or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.
Basic skills: Ability to add, subtract, multiply, and divide all units of measure using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to interpret bar graphs.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this Job, the employee is frequently required to sit, talk and hear. The employee is regularly required to walk,and reach with hands and arms. The employee is occasionally required to stand, use hands to finger, handle or feel. The employee must regularly lift and /or move up to 25 pounds.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually quiet.
Midwestern University is an Equal Opportunity/Affirmative Action employer that does not discriminate against an employee or applicant based upon race; color; religion; creed; national origin or ancestry; ethnicity; sex (including pregnancy); gender (including gender expressions, gender identity; and sexual orientation); marital status; age; disability; citizenship; past, current, or prospective service in the uniformed services; genetic information; or any other protected class, in accord with all federal, state and local laws, including 41 C.F.R. 60-1.4(a), 250.5(a), 300.5(a) and 741.5(a). Midwestern University complies with the Smoke-Free Arizona Act (A.R.S. 36-601.01) and the Smoke Free Illinois Act (410 ILCS 82/). Midwestern University complies with the Illinois Equal Pay Act of 2003 and Arizona Equal Pay Acts.