Regulatory and Compliance Manager

08-Apr-2024

Harvard T.H. Chan School of Public Health

65363BR

Job Summary

The Pediatric HIV/AIDS Cohort Study (PHACS) network conducts several longitudinal cohort studies investigating the long-term effects of exposure to HIV and ARV (antiretroviral) medications in infants, children, adolescents, and young adults who were born to persons living with HIV. The PHACS Data Resources and Scientific Administrative Cores (DRC and SAC) provide leadership for the development and implementation of research protocols and analyses for PHACS network studies, overseeing study activities at 21 clinical research sites, as well as multiple other contributing organizations.

The Health Outcomes around Pregnancy and Exposure to HIV/Antiretrovirals (HOPE) study, is enrolling and following women living with HIV (WLHIV), including those with perinatally acquired HIV (PHIV), to address critical scientific questions around the impact of HIV infection on women’s health. The HOPE study leverages the unique research infrastructure of PHACS to create a platform for exploring the multilevel dynamic determinants and mechanisms that influence the short and longer-term health of WLHIV over their lifecourse.

Position Description

The Epidemiology Department is seeking a Regulatory and Compliance Manager for all PHACS-affiliated research projects.  This person will manage the complex communications, coordination and documentation associated with the use of a single Institutional Review Board (sIRB) across these multi-site studies and will serve as the primary point of contact between the Harvard Longwood Campus (HLC) IRB and all PHACS-affiliated studies. Additionally, this person will have responsibility for ensuring that all compliance concerns affecting PHACS-affiliated studies are monitored and responded to as needed.

The Regulatory and Compliance Manager's duties include, but are not limited to, the following:

• Establishing relationships and maintaining close communications with a wide variety of constituents and stakeholders across protocol teams, study sites, institutional offices, and collaborating entities
• Working with and advising the PHACS-affiliated Principal Investigators (PIs), Protocol co-Chairs, Protocol Specialists, Project Director, Program/Project Managers, and study teams to ensure that all new and revised protocols are designed in compliance with the NIH Single IRB Policy for Multi-Site Research and the revised Federal Policy for the Protection of Human Subjects (the Common Rule)
• Implementing and revising, as necessary, a robust and well-organized system to oversee and track the day-to-day management of the reliance agreement and all regulatory aspects of the protocol submission, modification, and maintenance processes for all PHACS-affiliated studies
• Collaborating with the Streamlined, Multisite, Accelerated Resources for Trials IRB Reliance platform (SMART IRB) system, the Harvard Office of Regulatory Affairs and Research Compliance (ORARC), the HLC IRB, and the PHACS-affiliated PIs, Protocol Chairs, Protocol Specialists, study sites and their IRBs to ensure the continued smooth and time-sensitive transition from local institutional review to ceded review of all PHACS-affiliated projects
• Serving as the liaison between the PHACS-affiliated study sites and the HLC IRB, and providing communications, resources, timelines, training and office hours to facilitate collaboration and study staff training and introduce changes, as needed
• Managing communication with the HLC IRB, the PHACS-affiliated study sites, and their local IRBs to ensure continuously successful submissions and reviews of new protocols and materials, protocol modifications and reportable information, as well as regulatory compliance and operations
• Serving as the intermediary between the HLC IRB and the participating sites, and assisting sites with responding to requests from the HLC IRB and local IRBs
• Facilitating the continuing IRB review for all PHACS-affiliated studies, as applicable, at the HLC IRB
• Maintaining a working knowledge of all PHACS-affiliated protocols, ORARC and HLC IRB procedures, guidelines and policies, applicable local institutional guidelines and procedures, and all current NIH, US Department of Health and Human Services, and Office of Human Research Protection regulatory policies
• Managing and maintaining required regulatory and compliance documentation for all PHACS-affiliated studies
• Performing other duties to support PHACS-affiliated studies as needed

Basic Qualifications

• Bachelor's Degree or equivalent experience required
• 3+ years of related experience required
• Experience with human subjects research is required

Additional Qualifications and Skills

The following job-specific skills and competencies are preferred:

• Previous experience working with multi-site studies and the sIRB review process
• Solid working knowledge of federal and state regulations governing human research and Good Clinical Practice guidelines strongly preferred
• Excellent organizational skills and attention to detail
• Strong writing, editing and verbal and written communication skills
• Communicates quickly and effectively with a wide range of stakeholders
• Project management skills
• Strong analytical skills and problem solving skills
• Works well independently and with all levels of staff, faculty, and external contacts
• Experience prioritizing and multi-tasking in a busy environment while maintaining superior customer service  
• Strong skills in using discretion with sensitive and confidential information

• Awareness of and aptitude to appropriately and effectively understand, respect, and adapt to cultural and identity-based difference within group environments
• Knowledge of and commitment to concepts and issues tied to social justice, diversity, equity, and inclusion
• Skills related to creating and supporting an environment that allows for inclusion, effective intercultural engagement, and personal humility and authenticity
•  Experience fostering and reinforcing an environment that values unique experiences, cultures, backgrounds, and goals

Additional Information

Join the Harvard T.H. Chan School of Public Health to support our mission of health research and education, and to be a part of the oldest institution of higher learning in the country!

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• The Harvard T.H. Chan School of Public Health does not provide visa sponsorship, now or in the future, for staff positions.
• Harvard University requires pre-employment reference checks and background screenings.
• This position has a 90 day orientation and review period. The O&R period will be waived for any internal Harvard employee transfers.

Work Format Details

This is a hybrid position that is based in Massachusetts. Additional details will be discussed during the interview process. All remote work must be performed within one of the Harvard Registered Payroll States, which currently includes Massachusetts, Connecticut, Maine, New Hampshire, Rhode Island, Vermont, Georgia, Illinois, Maryland, New Jersey, New York, Virginia, Washington, and California (CA for exempt positions only). Certain visa types and funding sources may limit work location. Individuals must meet work location sponsorship requirements prior to employment.

About Us

The Department of Epidemiology, at the Harvard T.H. Chan School of Public Health, studies the frequency, distribution, and determinants of disease in humans, a fundamental science of public health. In addition to pursuing ground-breaking global research initiatives, we educate and prepare future medical leaders and practitioners as part of our mission to ignite positive changes in the quality of health across the world.

Benefits

We invite you to visit Harvard's Total Rewards website (https://hr.harvard.edu/totalrewards ) to learn more about our outstanding benefits package, which may include:

• Paid Time Off: 3-4 weeks of accrued vacation time per year (3 weeks for support staff and 4 weeks for administrative/professional staff), 12 accrued sick days per year, 12.5 holidays plus a Winter Recess in December/January, 3 personal days per year (prorated based on date of hire), and up to 12 weeks of paid leave for new parents who are primary care givers.
• Health and Welfare: Comprehensive medical, dental, and vision benefits, disability and life insurance programs, along with voluntary benefits. Most coverage begins as of your start date.
• Work/Life and Wellness: Child and elder/adult care resources including on campus childcare centers, Employee Assistance Program, and wellness programs related to stress management, nutrition, meditation, and more.
• Retirement: University-funded retirement plan with contributions from 5% to 15% of eligible compensation, based on age and earnings with full vesting after 3 years of service.
• Tuition Assistance Program: Competitive program including $40 per class at the Harvard Extension School and reduced tuition through other participating Harvard graduate schools.
• Tuition Reimbursement: Program that provides 75% to 90% reimbursement up to $5,250 per calendar year for eligible courses taken at other accredited institutions.
• Professional Development: Programs and classes at little or no cost, including through the Harvard Center for Workplace Development and LinkedIn Learning.
• Commuting and Transportation: Various commuter options handled through the Parking Office, including discounted parking, half-priced public transportation passes and pre-tax transit passes, biking benefits, and more.
• Harvard Facilities Access, Discounts and Perks: Access to Harvard athletic and fitness facilities, libraries, campus events, credit union, and more, as well as discounts to various types of services (legal, financial, etc.) and cultural and leisure activities throughout metro-Boston.

Job Function

General Administration

Department Office Location

USA - MA - Boston

Job Code

405012 Admin Professional (N)

Work Format

Hybrid (partially on-site, partially remote)

Union

55 - Hvd Union Cler & Tech Workers

Appointment End Date

31-Jul-2025

Pre-Employment Screening

Criminal, Education, Identity

Commitment to Equity, Diversity, Inclusion, and Belonging

At the Harvard T.H. Chan School of Public Health, we believe that diversity is integral to the Harvard experience and our mission of improving public health education, research and policy. Diversity of cultural backgrounds, identities, lived experiences, perspectives, and ways of understanding the world enriches our community and enables us to best meet the public health needs of the United States and the world. Ongoing learning and development related to diversity allows for both individual and institutional growth, and is necessary to foster and sustain a culture of inclusion. To achieve this, we are committed to ensuring equitable access to opportunities for learning, living, and working at the Harvard Chan School. We maintain an unwavering dedication to diversity, inclusion, and belonging as core to our institutional values and to actively counter, minimize, and address racism, sexism, xenophobia, homophobia, gender bias, and all forms of discrimination.

Learn more about the School’s mission, objectives, and core values , our Principles of Citizenship , and our diversity, inclusion, and belonging initiatives.

EEO Statement

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, gender identity, sexual orientation, pregnancy and pregnancy-related conditions, or any other characteristic protected by law.

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