Associate Director, Human Research Protection Program

Brandeis University is delighted to announce a career opportunity for an Associate Director, Human Research Protection Program (HRPP) in the Office of Research Administration. If you are looking for an opportunity to work at a beautiful university campus with lots of perks including free parking and access to a top of the line athletic facility, look no further At Brandeis we offer a competitive benefits and compensation package which includes medical, dental and life insurances. If you hope to advance your career through educational opportunities, Brandeis offers tuition benefits for employees, dependents and spouses. Our 403b retirement savings plan includes a generous match.

Brandeis University’s Human Research Protection Program (HRPP) promotes the welfare and rights of human research participants, facilitates excellence in ethical human research, and provides timely and high-quality IRB review, education and outreach, and monitoring of all research activities involving human subjects.

As a member of the Office of Research Administration leadership team, the Associate Director, Human Research Protection Program works with, and reports to, the Associate Provost for Research Administration. The Associate Director is responsible for ensuring that the Brandeis University HRPP operates in compliance with all relevant federal regulations, state and local laws, and institutional policies and procedures. The Associate Director provides leadership in human subject research to faculty, staff, and student investigators to foster a culture of compliance and responsible conduct of research. Additionally, this role will develop and implement strategic priorities, continuous evaluation of the program, implementation of meaningful quality improvement including eventual AAAHRP accreditation, and continue to build Brandeis University’s HRPP through maintaining and developing new partnerships with other colleges and universities.

Key responsibilities:

Regulatory/Strategic Program Management & Development (70%)

- Stays fully abreast of all proposed changes in federal and state regulations and laws affecting the participation of human research participants and plays a leadership role in developing and submitting an institutional response. Leads the development of institutional policies and procedures for the protection of human research participants. Provides guidance regarding the interpretation of regulations, laws, and policies to the organization’s IRB, researchers, staff, and administrators that meets the needs of our research community.
- Ensures all protocols are reviewed in accordance with all federal, local, and institutional regulations and policies and ensures all IAA and IIAs are in compliance. Maintains an active portfolio of investigators and conducts protocol review and analysis for these investigators.
- Oversees updates to all HRPP materials including development/changes of forms, applications and instructions, the HRPP website, training materials, and other administrative tools supporting the work of the office and the investigators.
- Provides regular communication about human subjects’ research, the HRPP Office, and other information to the research community to ensure uninterrupted compliance and efficient operations. Regularly creates content for and updates to the HRPP website. In collaboration with the Associate Provost for Research Administration, serves as the relationship manager with the current partnerships with other institutions who are covered by Brandeis’s IRB. Continues to expand and cultivate new partnerships with additional institutions to expand the purview of the Brandeis HRPP. Ensures Brandeis University and partner institutions are maintaining the terms of their agreements.
- Negotiates and maintains the Federal Wide Assurance (FWA), all agency-specific agreements, the IRB registration(s), and cooperative agreements necessary to ensure compliance with federal requirements. Ensures any clinical trials are appropriately registered and reporting requirements are met. Serves as liaison with federal officials and national organizations as appropriate.
- Manages and implements the development of HRPP program work towards AAHRPP accreditation, leading coordination of accreditation activities including site visits and responding to issues raised by AAHRPP, as the institution progresses towards accreditation.
- Ensures that research projects of a special nature, such as clinical trials or research conducted outside of the United States, among other types, are approved and documented in accordance with federal and local regulations, and is knowledgeable in the application of relevant international law pertaining to human subjects’ research conducted under the purview of the institution’s IRB.
- Provides leadership in all day-to-day operations of the HRPP Office and the IRB, including all protocol review, IRB committee work, and IIAs and IAAs. Works with ORA leadership to establish and prioritize work plans and long-range goals for the enhancement of the HRPP. Continually assesses the current state of research and pursues a strategic plan that supports future strategic growth as it pertains to human subject research protection, including resource and FTE needs, programmatic needs and necessary compliance initiatives.

Institutional & Office Operations (30%)

- Provides leadership, training, and guidance to the Institutional Official, IRB Chair and members, the HIPAA Privacy Board, and the research community to ensure compliance with federal regulations with the aim of the protection of human subjects. Actively identifies educational needs and establishes on-going education and communication of regulatory changes and alterations to the human subject research landscape; provides customized presentations to individuals and groups, courses, and departments and partner institutions on issues relating to HSR, particularly regarding the purpose and relevance of the IRB and its policies and procedures. Actively builds relationships with all members of the HSR community to become a trusted partner in the research process and contribute to the culture of compliance at Brandeis University. Ensures all required training by community members is completed and up-to-date.
- Serves as the direct supervisor and knowledgeable, inspirational resource for IRB staff, including training of staff, promoting career development, tracking performance, conducting annual performance evaluations, and providing guidance in efficient office operations, delegation, and human research regulations with the goal of building and maintaining a highly skilled, talented, deeply knowledgeable, adaptable team to support the work of the office, maintaining a culture of excellence, and superior customer service.
- Oversees the quality assurance and compliance monitoring of the HRPP, including research protocols, training requirements, and investigation of matters of non-compliance. Ensures implementation of corrective action, as needed, in accordance with Brandeis policies and IRB policies and procedures.
- Has mastery over and is ultimately responsible for all HRPP systems and tools that support all application, review, tracking, and communication processes associated with human research protection. Responsible for all HRPP record keeping, the development, maintenance, and accuracy of all HSR data in the ORA database, appropriate archiving and destruction of all HRPP materials and protocols. Defines and leads process improvement initiatives including reviewing and analyzing workflow for excellence and efficiency, defining and tracking metrics, preparing and presenting reports on office and IRB-related activities on an annual basis and upon request. Defines and oversees communication enhancements and quality assurance/quality improvement plans.
- Works with the Associate Provost for Research Administration to recruit HRPP and train staff and appoint IRB members in accordance with regulations. Identifies the need for replacing members when resignations occur or when terms expire and recruits and recommends non-affiliated members and evaluates recommendations for scientist and non-scientist members. Serves as an IRB Committee member to assist as needed with the review of complex or time sensitive research protocols, requiring a higher level of understanding of the federal regulations and institutional policies.
- Other duties, as assigned.

Specific Projects & Responsibilities

- Work with Associate Provost for Research Administration to cultivate new partnerships with other institutions for Brandeis to serve as their IRB of record; manage transitional processes for each new institution.
- Prepare Brandeis to become AAAHRP accredited and oversee initial accreditation process.

Education & Work Experience:

- Bachelor’s Degree required; Master’s degree preferred
- 5-8 years in higher education administration or a related field required; and a minimum of five (5) years of IRB experience; supervisory experience.

Additional Requirements:

- Expertise in regulations pertaining to the protection of human subjects, including HHS, FDA, and HIPAA.
- Knowledge of Microsoft Office Programs: Word, Excel, PowerPoint; Google Suite Programs: Gmail, Google Docs, Google Sheets, Google Forms, etc.; Internet Functions; Adobe Professional; FileMaker Pro.
- Project management experience with a demonstrated ability to manage projects to tight deadlines, within budget with minimal oversight.
- Demonstrated ability to manage ambiguity and be able to juggle and prioritize multiple time-sensitive demands in a rapidly changing organization and environment.
- Demonstrated dynamic leadership, innovation in administrative and institutional infrastructure building, and strategic thinking.
- A collaborative and inclusive professional style, ability to build strategic relationships with staff, faculty and students at all levels, excellent organizational and communication skills (written, verbal, listening), ability to make strategic connections, and the utmost respect for discretion, confidentiality and professionalism.
- Excellent ability to communicate complex concepts to a lay audience, effectively train and develop staff to a high level of competency, and develop and present training materials for broad audiences.
- Strong data management and analytical skills with an ability to prepare and present complex information effectively.

Commitment to Diversity, Equity, and Inclusion

Diversity, equity and inclusion are important values at Brandeis today and always have been for they are rooted in our founding as an institution. These values serve as a reminder for self-reflection, and a continuous call to grow for us as Brandeisans. Founded as a model institution for ethnic and religious pluralism, Brandeis University welcomes students, faculty, and staff of all nationalities, religions, and orientations. Moreover, social justice is central to the mission of Brandeis, which endeavors to foster a just and inclusive campus culture that embraces the evolving diversity of our larger society. Read more online about our Mission and Diversity Statements at Brandeis Mission and Diversity Statements.

If you are interested in a role and have relevant experience but your work history does not align perfectly with every qualification in the job description, we nevertheless encourage you to apply.

Closing Statement

Brandeis University is committed to providing its students, faculty and staff with an environment conducive to learning and working and where all people are treated with respect and dignity. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, ancestry, national origin, ethnicity, caste, sex, pregnancy, sexual orientation, gender identity/expression, including transgender identity, religion, disability, age, genetics, active military or veteran status and any other characteristics protected under applicable federal or Massachusetts law.