PRIM&R accepts advertisements from all institutions seeking to hire for positions in animal and human research ethics and related fields, such as research administration and ethics education; listing does not imply endorsement of the lister or of the qualifications stated for a position.
The University of Miami is among the top research universities and academic medical centers in the nation, and one of the largest private employers in South Florida.
With more than 16,000 faculty and staff, the University strives for excellence, and is driven by a powerful mission to transform and impact the lives of its students, patients, members of the community, and people across the globe.
The University is committed to fostering a culture of belonging, where everyone feels valued and has the opportunity to add value. Through values of Diversity, Integrity, Responsibility, Excellence, Compassion, Creativity, and Teamwork (DIRECCT) the U community works together to create an environment driven by purpose, excellence, community, and service.
The Office of the Vice Provost for Research has a great opportunity for a Director, Human Subject Research (HSRO) at the University of Miami Medical campus.
CORE JOB SUMMARY
The Director, Human Subject Research (HSRO) oversees and manages the organization’s Human Subject Research Office (HSRO) and Institutional Review Boards (IRBs). The Director provides leadership and vision for the HSRO/IRBs, oversees development, policies, procedures and programs in compliance with federal regulations, state laws and institutional polices. The Director develops and maintains collaborative relationships with internal and external stakeholders, establishes a culture of respect for human research participants, ensures a timely and thorough review and approval of research protocols; and assures that education and training programs for the HSRO, IRB, and research community are up to date and effective.
CORE JOB FUNCTIONS
Collaborates with UM Human Research Protection Program (HRPP) partners, establishes processes to ensure that the HRPP mission and goals are attained while facilitating a seamless approach to human subject protection and human subject research administration.
Serves as the lead contact for reviews and inquiries from the Association for the Accreditation of Human Research Protection Programs (AAHRPP).
Assesses HRPP policies and practices for alignment with federal and state regulations, local laws, Institutional policies, AAHRPP accreditation standards and best ethical practices related to human subjects research.
Ensures that human research protection training is available and completed by investigators, key study personnel, the Institutional Signatory Official, and all University of Miami staff who participate in the human subjects protection program.
Provides guidance regarding the interpretation of regulations, laws, and policies to the organization’s IRBs, researchers, staff, and administrators.
Ensures efficient and compliant processes for review, approval and oversight of human research.
Assesses existing and future program needs. Establishes strategic plans developing goals and objectives for the HSRO/IRB and metrics for their evaluation.
Prepares and presents reports to the appropriate committees or senior leaders.
Guarantees the periodic performance review of the IRB membership and its composition.
Assists in recruiting prospective IRB chairs and members and makes recommendations to Institutional Official.
Maintains current knowledge of changes in rules and regulations, and informs all relevant parties of any material changes.
Conducts trainings and ensures the development and implementation of training and educational materials and activities for University faculty, administrators, and staff.
Works with the AVP, Senior Manager of Finance and Director of Business Operations to prepare and oversee the annual budget.
Establishes and continuously assesses the effectiveness of the internal controls within the unit and compliance with University policies and procedures.
Ensures employees are trained on controls within the function and on University policy and procedures.
This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.
Bachelor’s degree in relevant field required. Master’s degree in an appropriate scientific, legal, or business discipline (e.g., J.D., M.S., M.B.A. or Ph.D.) is highly preferred.
Certification and Licensing:
Certified IRB Professional (CIP) preferred
Minimum 5 years of relevant experience in IRB-related activities with four (4) years in a supervisory capacity. Prior experience in HRPP administration. Expert knowledge in federal, relevant international and state human subject regulations. Proven experience working collaboratively with researchers, federal authorities and Board members and with administering and overseeing human subjects electronic management systems.
Preferred: HRPP and IRB experience in a university or academic medical center setting; research administration experience in a compliance and/or regulatory environment; experience with and thorough knowledge of Institutional policies regarding the protection of human subjects participating in research; experience in presenting professional seminars or lectures at the national conference level and with national organizations concerned with the protection of human subjects. Any appropriate combination of relevant education/or work experience may be considered.
Knowledge, Skills and Attitudes:
Demonstrated leadership, management, operations and problem-solving skills.
Demonstrated ability to work effectively with other Institutional entities within the HRPP.
Open and candid individual with excellent diplomatic and negotiating skills
Demonstrated commitment to the principles underlying UM’s cultural values and service standards
Ability to maintain effective interpersonal relationships
Ability to communicate effectively in both oral and written form
Skill in collecting, organizing and analyzing data
Proficiency in computer software (i.e., Microsoft Office)
Knowledge of business and management principles
Ability to lead, motivate, develop and train others.
Visit our career site at Miami.edu/careers. Keyword search R100040024
The University of Miami is considered among the top tier institutions of higher education in the U.S. for its academic excellence, superior medical care, and cutting-edge research. At the U, we are committed to attracting a talented workforce to support our common purpose of transforming lives through teaching, research, and service. Through our values of Diversity, Integrity, Responsibility, Excellence, Compassion, Creativity and Teamwork (DIRECCT) we strive to create an environment where everyone contributes in making UM a great place to work. We are one of the largest private employers in Miami-Dade County; home to more than 13,400 faculty and staff from all over the world.