"Executive Director, Human Research Protection Program"

Job Description

The University of Maryland, Baltimore's Human Research Protection Program has an opportunity for an Executive Director, Human Research Protection Program. The selected candidate will ensure compliance of all human research with related laws and regulations. This role oversees the review process for all related human research requests, non-human research requests, and determinations of Exempt from IRB oversight. This position requires 24-hour availability and financial disclosure reporting required by State of Maryland Ethics Commission.

The University of Maryland, Baltimore (UMB) is the State's public health, law and human services university devoted to excellence in professional and graduate education, research, patient care, and public service. As a diverse community of outstanding faculty, staff and students, and using state-of-the-art technological support, we educate leaders in health care delivery, biomedical science, global health, social work and the law. We emphasize interdisciplinary education and research in an atmosphere that explicitly values civility, diversity, collaboration, teamwork and accountability. By conducting internationally recognized research to cure disease and to improve the health, social functioning and just treatment of the people we serve, we foster economic development in the City, State, and nation. We are committed to ensuring that the knowledge we generate provides maximum benefit to society and directly enhances our various communities.

The Human Research Protection Program is a comprehensive system to ensure the protection of the rights and welfare of subjects in Human Research and is accredited by the Association for the Accreditation of Human Research Protection Programs. The Office of Accountability and Compliance (OAC) provides administrative support for the UMB Institutional Review Board (IRB) which conducts ethical review, compliance, and oversight activities for over 1,800 human research protocols. The office provides education and training for over 2000 investigators and staff involved in research involving human subjects.

Benefits Information

UMB offers a comprehensive benefits package that prioritizes wellness, work/life balance, and professional development, along with additional exciting perks that employees can take advantage of. This position participates in a retirement program that must be selected and is effective on your date of hire. Exempt regular staff receive a generous leave package that includes over 4 weeks of vacation accrued each year, paid holidays, unlimited accrual of sick time, and comprehensive health insurance; professional learning and development programs; tuition remission for employees and their dependents at any University System of Maryland school; and flexible work schedules and teleworking options (if applicable per job).

UMB is a public university and constituent institution of the University System of Maryland. All employees are expected to work primarily physically within the State of Maryland.

Primary Duties:

• Develops HRPP strategic and financial plans for approval by the Institutional Official.
• Manages relationships between internal clients and subject matter experts, and external oversight agencies, consultants, sponsors, and other professionals in circumstances involving human subjects.
• Responsible for ensuring ongoing accreditation of UMB's HRPP.
• Provides strategic direction for the Human Research Protection review process, to include establishing goals, target groups, and desired outcomes. Develops and maintains standard operating procedures.
• Prepares, coordinates, and maintains program content and delivery methods for training and educating researchers on corrective measures and actions. Establishes service guidelines for all constituents.
• Examines and evaluates program effectiveness and makes changes as necessary.
• Coordinates the use of department resources to effectively review and approve requests.
• Organizes and/or participates in various IRB committees and teams to consult with program heads and administrative officials on Human Research policy and program needs and issues.
• Interacts with various federal agencies regarding the compliance of the program. Serves as Human Protections Administrator of UMB Federal-wide Assurance.
• Provides support to IRB Coordinators, IRB Administrators, and IRB Analysts in the approval process.
• Participates on campus leadership committees that include IRB Executive Committee, BVAMHCS Research and Development Committee.
• Provides advice and recommendations, which may serve as a basis for policy decisions in areas related to the ethical study of human research subjects. Consults with investigators about associated issues and ethical concerns.
• Oversees the continuing quality improvement of services pertaining to human subjects' research for the Institutional Review Board, Investigators, and Research Personnel.
• Oversees the development and training of UMB, investigators, IRB members, and research personnel.
• Performs other related duties as assigned.

Qualifications

Education: Bachelor's degree in Health Sciences or a related field (Master's degree and additional certification is preferred and can be used to substitute for relevant experience).
Experience: Six (6) years spent progressively building a background in human subjects research, IRB administration, and compliance oversight, preferably in an academic setting.
Supervisory Experience: Three (3) years of experience at a management/leadership level.
Certification/Licensure: Certified IRB professional (either current or within 6 months of hire).
Other: Except for qualifications established by law, additional related experience and formal education in which one has gained the knowledge, skills, and abilities required for full performance of the work of the job class may be substituted for the education or experience requirement on a year-for-year basis with 30 undergraduate college credits being equivalent to one year of related experience. In instances where specific education and/or experience is required only directly related education and/or experience may be substituted.

Knowledge, Skills, Abilities

Knowledgeable in the provision of the Common Rule (45CFR46), FDA regulations, ICH Good Clinical Practice Guidelines, and other relevant requirements and guidelines related to the ethical study of human research subjects. Thorough knowledge of position requirements. Thorough knowledge of all applicable requirements, regulations, and laws. Skill in effective use of applicable technology/systems. Ability to effectively communicate both verbal and written thoughts, ideas, and facts. Ability to support a mission and strategic vision. Instructional, training, and teambuilding skills to strengthen and cultivate relationships. Skill in consultation and change management. Ability to demonstrate, understand, apply, and adhere to the UMB Core Values of Respect and Integrity, Well-being and Sustainability, Equity and Justice, and Innovation and Discovery.

Hiring Range:

$160,000 - $175,000, commensurate with education and experience.