Job Details

Harvard University
  • Position Number: 2450013
  • Location: Cambridge, MA
  • Position Type: Laboratory and Research
IRB Review Specialist
Harvard T.H. Chan School of Public Health

Job Summary:
The Office of Regulatory Affairs and Research Compliance (ORARC) ensures the quality and integrity of research conducted at the Harvard T.H. Chan School of Public Health. ORARC is responsible for a broad range of regulatory affairs and research compliance functions, which require coordinating with various Harvard departments in areas such as conflicts of interest, data and information security, research integrity, intellectual property, animal research and biological safety. ORARC also oversees efforts in international research compliance, which includes the review of institution collaboration agreements/MOUs, and providing global research ethics training.

ORARC provides administrative support for the Harvard Longwood Campus (HLC) Human Research Protection Program (HRPP), which acts as shared service across the Harvard Longwood Medical Area (LMA) Schools (Harvard Medical School, Harvard School of Dental Medicine, and Harvard T.H. Chan School of Public Health). The two primary units of the HLC HRPP include its Quality Improvement Program (QIP) and Institutional Review Board (IRB) Operations. The IRB Review Specialist is a critical member of the IRB Operations staff who is primarily responsible for performing designated review for assigned departments across the Harvard LMA Schools.

Job-Specific Responsibilities:

Duties and responsibilities include, but are not limited to, the following:

Serve as a member of the Harvard Chan School and Harvard University Faculty of Medicine IRB panels and participate, as prompted by department assignments and submissions, in convened IRB review of non-exempt human research (initials, continuing reviews, and modifications) and reportable new information, including adverse events and violation reports in accordance with federal, state, and local laws and regulations, School and University Policies and Procedures. When applicable, participate in agenda check in meetings prior to meeting preparation. When applicable, draft and submit submission-specific meeting minutes to the Associate Director of IRB Operations in a timely manner

Work independently, exercise the authority to make not-human-subjects research and/or exemption determinations; approve non-exempt minimal risk research using the expedited review procedure; approve minor changes in approved research not otherwise eligible for expedited review; review reportable new information; review financial conflict of interest reports, and prepare submissions for monthly convened IRB meetings

Serve as primary contact for assigned departments: provide accurate guidance, recommendations, best practices, and explanations to faculty, staff, and students in a timely manner

Review, assess, assign, and route incoming correspondence and IRB submissions in a timely manner; anticipate and resolve problems; keep ORARC leadership informed of project(s) status

Update and maintain ESTR system, internal tracking logs, and electronic filing system; draft, edit and prepare correspondence (including convened IRB review notification letters), reports and other material using word processing, spreadsheets and/or databases

Maintain active knowledge of evolving laws, regulations, policies, and ethical norms that are applicable to human research activities through continuous professional development

Participate in ORARC educational activities and workshops, including IRB member education, QIP education series, and department-specific sessions, as needed

Other duties as assigned

PLEASE NOTE: Shortlisted candidates will be required to conduct a (written) sample IRB application review to demonstrate regulatory and review knowledge.

PLEASE NOTE: The finalist for this position must have the Certified IRB Professional (CIP) designation or be CIP-eligible. If the successful applicant does not already possess the CIP designation, they will be required to obtain it within 1 year of start date -- and the CIP status must be maintained in good standing throughout employment as IRB Review Specialist.

PLEASE NOTE: The primary work location for this position is Boston, Massachusetts. Until our return to campus, which is still to-be-determined though we are working with a pilot schedule at this time and through the fall, this interview process and position will be conducted virtually – including virtual interviews, remote onboarding, and remote work. The remote nature of this position is only temporary. Local, on-campus work will be required as a condition of continued employment once the School and this role return to an operational status that supports it.

Basic Qualifications:
Bachelor's degree or equivalent experience required
3+ years of directly related experience required
Demonstrated knowledge and understanding of federal regulations and guidance governing human research required

Additional Qualifications:

The following job-specific skills and competencies are preferred:
Master's degree in a related field
Experience with an eIRB submission system
Experience maintaining strict standards of confidentiality
Strong analytical, written, and oral communication skills, and experience multi-tasking in a busy office environment while maintaining superior customer service
Experience using multiple technical applications including word processing, database management, spreadsheets, graphics and presentation software, electronic calendar, email, and other technical applications

The following cultural competencies are also preferred:

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

Additional Information:
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 and our diversity, inclusion, and belonging initiatives.
Harvard University offers an outstanding benefits package including:
Time Off: 3-4 weeks paid vacation, paid holiday break, 12 paid sick days, 12+paid holidays, and 3 paid personal days per year.

Medical/Dental/Vision: Excellent and affordablemedical, dental & vision plans, with coverage beginningas of an employee's start date.

Retirement: University-funded retirement planwith full vesting after 3 years of service.

Tuition Assistance & Reimbursement Programs: $40 per class at the Harvard Extension School, discounted options through participating Harvard graduate schools, and reimbursement options for accredited schools outside of Harvard.

Transportation: 50% discount on MBTA passes, as well as additional options (rideshare, biking, etc.) to assist employees in their daily commute.

Wellness & Professional Development: Programs and classes at little or no cost, including stress management, hard & soft skills development, career planning, massages, nutrition, meditation, and complimentary health services. Additionally, access to Harvard athletic facilities, libraries, campus events -- and many discounts for various cultural and leisure activities throughout metro Boston.

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!
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.
Harvard will require COVID vaccination for all Harvard community members who will have any on-campus presence. Individuals may claim exemption from the vaccine requirement for medical or religious reasons. More information regarding the University's COVID vaccination requirement and exceptions may be found at the University's "COVID-19 Vaccine Information" webpage.
APPLY HERE via Harvard Careers.

Copyright 2021 Inc. All rights reserved.

Posted by the FREE value-added recruitment advertising agency


By continuing to use our site, you agree to our Terms of Service and Privacy Policy. Learn more about how we use cookies by reviewing our Cookie Policy.