PROFESSIONAL POSITION DESCRIPTION

Position Title: REGULATORY COMPLIANCE ADMINISTRATOR

Division: PV

Department: ORIO

Location: PORTLAND CAMPUS with travel to all USM campuses

Schedule: Regular Full Time with evenings and weekends as required

Reports to: Assistant Provost for Research Integrity

STATEMENT OF THE JOB: The Regulatory Compliance Administrator (“RCA”) collaborates with the Assistant Provost to oversee risk management and regulatory compliance at USM, creating, modifying, updating, and documenting administrative compliance policies and facilitating the implementation of administrative policies. Specifically, they will oversee and coordinate operations related to Financial Conflicts of Interest (FCOI), Data Management Plans (DMPs),Radiation Safety (RS), Export Control, HIPAA as well as serve as a resource on Environmental Health and Safety regulations.

·  ESSENTIAL FUNCTIONS: Overseeing risk management for USM.

·  Developing, modifying, updating, and documenting compliance policies and procedures to assure smooth, logical, transparent, and customer-oriented service.

·  Assisting members of the USM community in working with UMS Office of Legal Counsel on complex agreements and contracts. This includes determining when a non-standard contract can be executed under the concept of minimal business risk.

·  Facilitating USM’s compliance with requirements related to the use of facilities funded with tax-exempt bonds. Reviews agreements with particular emphasis on identifying when a “private use” may exist. Working with staff in Academic Affairs and other areas to regularize and document the compliance requirements related to the instruments, facilities and the uses made within the facilities.

·  Oversees and coordinates operations relating to Data Management Plans (DMPs) for USM externally funded projects.

·  Advises and supports the Radiation Safety Committee (RSC) and Financial Conflict of Interest Committees (FCOI) for USM. The RCA may also be asked to help with the administration and review of IRB and HRPP protocols.

·  Reviews federal, state and local laws and regulations for requirements and is responsible for providing this information to customers of ORIO.

·  Works closely with the Assistant Provost to advise faculty, staff and students (individually or in groups) about regulatory compliance.

·  Serves as a voting member of the RSC.

·  Assist in Hazard Communication and Hazardous Waste Collection, Handling/storage, document submittal, etc.

·  In collaboration with the Assistant Provost provides technical assistance and guidance to the Greater Portland community.

ANCILLARY FUNCTIONS

·  Additional duties as reasonably assigned.

·  Advises and supports the research compliance boards

·  Collaborates with community partners utilizing USM’s research compliance committees. Will also provide guidance on developing policies and procedure and screening their materials to the compliance committees. The RCA will make recommendations in accordance with Federal, State, and local law and regulations and USM policy regarding the level of review necessary for the materials.

·  Assists the Assistant Provost in developing USM educational resources and seminars including preparation of educational materials and presentations.

·  Assists in maintaining a library of current and emerging Federal, State and Local laws and regulations.

·  In collaboration with the Assistant Provost prepares regular reports (annual and monthly).

·  Assist in grant writing in research integrity and regulatory compliance.

SPECIAL ESSENTIAL FUNCTIONS/RESPONSIBILITIES*:

·  Direct access to or responsibility for controlled or hazardous substances.

·  Ability to provide own transportation (fully-insured vehicle), provide proof of a valid driver’s license, and compliance with Maine law regarding vehicle insurance.

·  Work on federally funded projects.

SUPERVISORY RESPONSIBILITIES:

Responsible for the task or project supervision of student employees, interns and/or Graduate Assistants. Demonstrates knowledge and experience in maintaining a safe working/learning environment

BUDGET RESPONSIBILITIES:

Collaborates with the Assistant provost to prepare the ORIO Annual Budget, including estimating/forecasting budgetary needs for upcoming compliance activities and establishing budgetary priorities.

PUBLIC AND PROFESSIONAL ACTIVITIES RELATED TO JOB PERFORMANCE:

Provides broad public service activities such as training and guidance to the greater Portland community on regulatory and research compliance. The RCA is encouraged to participate in conferences, professional associations, and local and regional committees.

INTERNAL AND EXTERNAL CONTACTS:

·  Interact with USM personnel at all levels. Maintain collegial working relationships with University of Maine System staff and compliance and legal staff of UMS Universities, higher education colleagues, professional organizations and regulatory agencies

·  Considerable external contact with other Universities in the University of Maine System and other organizations formally collaborating with USM.

·  Considerable external contact with the greater Portland community on regulatory and research compliance matters.

·  In collaboration with Assistant Provost, will serve as a deputy negotiator (or serve as lead negotiator in the Assistant Provost’s absence) representatives of Federal Agencies such as National Institutes of Health, Public Health Service, Food and Drug Administration and Department of Defense.

KNOWLEDGE, SKILLS, AND ABILITIES:

·  Knowledge of Federal and State regulations governing, research, privacy protection, , data management, financial conflicts of interest, environmental health and safety;

·  Analytical and critical thinking skills, along with the ability to communicate effectively and in a positive manner;

·  Able to work in a dynamic team environment, as well as independently;

·  Able to clearly communicate and translate complex regulations and policies to lay persons, faculty, staff, and students;

·  Able to assimilate large amounts of legal and regulatory information, translate into appropriate policies and procedures, and be able to apply these over a large spectrum and multiple disciplines.

·  Demonstrated ability to work independently, balance multiple priorities, and meet deadlines.

QUALIFICATIONS:

Required:

·  Juris Doctorate (JD) and some related experience in regulations or comparable BS plus five years’ experience or MS plus 3 years' experience in an academic office, research, health care or other appropriate office routinely dealing with regulatory matters or a graduate degree in health policy, law or ethics. Positive verbal communication skills. Ability to work independently with little direct supervision. Computer proficiency in spreadsheet, database, e-mail, and word processing applications. Must possess the ability to learn Federal and State regulations, administrative procedures, and effectively communicate these regulations to faculty and staff verbally, and in writing

License:

·  Valid motor vehicle driver’s license

Preferred:

·  Degree in health policy, public policy, environmental hygiene, science, law or ethics. Previous regulatory compliance work implementing policies, and quality assessment of these or other activities. Computer proficiency in Filemaker. Knowledge of University Policies and Procedures and Federal Research guidelines.

*NOTE: All individuals who are recommended to fill and subsequently offered a position with special essential responsibilities as listed above, or other licensure or certification, shall have the following additional applicable background screening completed (in addition to regular and standard background screening) based on the responsibilities of the position: Credit history screening, and/or Sex offender registry screening, and/or Federal criminal history screening and/or License/certification verification.

For Human Resources Use

Date Approved: 06/01/2015

Job Family: 11

Salary Band: 105

Unit: UMPSA

CUPA code: 325000

Employee: TBD

Position #: 00021506