Skip to main content

This job has expired

Research Compliance Coordinator

Job Details

Job Summary

The Research Compliance Coordinator is part of the Research Policy and Compliance team that supports the faculty and research labs in the Harvard Stem Cell and Regenerative Biology department (HSCRB) as well as the iPS Core Facility. Reporting directly to the Senior Research Compliance Manager, the Coordinator will prepare applications for new and renewing IRB and Embryonic Stem Cell Research Oversight (ESCRO) protocols, as well as contracts related to research with human subjects, human biospecimens, and/or human data. The Coordinator will also act as the point person for the administrative operations of the iPS Core Facility, coordinating the execution of fee-for-service agreements and the distribution of human stem cell lines from the iPS Core biorepository.

Auto req ID

60807BR

Job Code

403040 Coordinator II

Department Office Location

USA - MA - Cambridge

Business Title

Research Compliance Coordinator

Sub-Unit

Sciences

Salary Grade

055

Time Status

Full-time

Union

55 - Hvd Union Cler & Tech Workers

Basic Qualifications

A minimum of 5 years of related experience working in research, research administration, or compliance. Education beyond high school may count towards experience.

Additional Qualifications and Skills

College degree strongly preferred, or an equivalent of education plus relevant business experience.

Excellent ability to organize and maintain files, prioritize duties, and communicate clearly.

Experience in detail-oriented role.

Additional Information

iPS Core Facility: In addition to its fee-for-service operations, the HSCI iPS Core Facility serves as a biorepository for induced pluripotent stem cell lines (iPS cell lines) and human embryonic stem cell lines (hES cell lines) generated by HSCI scientists; the Core distributes these cells to the broader scientific community for research use, for a fee.

Department

Stem Cell and Regenerative Biology

Pre-Employment Screening

Identity

Schedule

Monday-Friday, 9-5

Job Function

General Administration

Position Description

Specifically, the Research Compliance Coordinator will be responsible for:

· Drafting, editing, and submitting IRB and ESCRO applications, annual renewals, amendments, and reports in compliance with federal and state law, NIH policies, and Harvard institutional policy. This work requires coordination with HSCRB faculty and research staff and their collaborators, external vendors and other providers of human biospecimens/data, as well as representatives of the Harvard IRB and ESCRO committees. Multiple steps must be coordinated, including but not limited to: ascertaining the provenance of human biospecimens/data; verifying that the proposed research is in fidelity with the informed consent form; assuring that any necessary Material Transfer Agreements (MTAs), Data Use Agreements (DUAs), or collaborative research agreements are in place; ensuring compliance with NIH policies related to the sharing of genomic sequencing data and the use of Human Fetal Tissue in research.

· Reviewing grant proposals for compliance with existing protocols; analyzing scientific research proposals to identify additional compliance documentation that is needed; coordinating with researchers, grants managers, and the Harvard Office for Sponsored Programs (OSP) to meet deadlines for securing funds.

· Collecting, reviewing, and organizing supporting regulatory documentation for submission with IRB and ESCRO protocols (e.g., informed consent forms, MTAs/DUAs, collaborative research agreements, correspondence with providers of biospecimens and data, ancillary approvals such as COMS and IACUC, etc.); maintaining internal database of IRB and ESCRO protocols and related information for internal tracking purposes and in the event of an audit.

· Serving as point person for iPS Core fee-for-service activities. Coordinating the execution of iPS Core service requests from U.S. and international customers including investigators at Harvard, Harvard-affiliated hospitals, non-profit organizations, foundations, and for-profit biotech companies; facilitating execution of service agreements by multiple parties at requesting institution and Harvard; maintain records of service agreements.

· Coordinating distribution of human pluripotent stem cells through the iPS Core biorepository. Handling cell line requests from a variety of U.S.-based and international customers, which includes facilitating MTA execution with the Office of Technology Development; validating approvals for the use of embryonic stem cells with the Harvard ESCRO committee; coordinating invoicing and payment with the HSCRB Business Operations team; liaising with iPS Core staff; and providing troubleshooting and customer support.

· Administering content for iPS Core Facility websites (main iPS Core website, fee-for-service request form, and cell distribution request platform).

School/Unit

Faculty of Arts and Sciences

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.

Working Conditions

New employees are required to be on campus 5 days a week during the 90-day orientation and review period. After the orientation period, this will be a hybrid position with a minimum of 2-3 days working on site.

Hours: Monday-Friday, 9-5

The health of our workforce is a priority for Harvard University. With that in mind, we strongly encourage all employees to be up-to-date on CDC-recommended vaccines.

Commitment to Equity, Diversity, Inclusion, and Belonging

Harvard University views equity, diversity, inclusion, and belonging as the pathway to achieving inclusive excellence and fostering a campus culture where everyone can thrive. We strive to create a community that draws upon the widest possible pool of talent to unify excellence and diversity while fully embracing individuals from varied backgrounds, cultures, races, identities, life experiences, perspectives, beliefs, and values.

Benefits

We invite you to visit Harvard’s Total Rewards website 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.
Work Format

Hybrid (partially on-site, partially remote)

Company

 Harvard FAS

The Faculty of Arts and Sciences is the home of Harvard’s undergraduate program (Harvard College, founded in 1636) as well as all of Harvard’s PhD. programs (the Graduate School of Arts and Sciences, founded in 1872). The 40 academic departments and more than 30 centers of the FAS support a community unparalleled in its academic excellence across the broadest range of liberal arts and sciences disciplines. Together, the FAS seeks to foster an environment of ambition, curiosity and shared commitment to knowledge and truth that elicits excellence from all members of our community and prepares the next generation of leaders through a transformative educational experience.

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert