Research Compliance Manager is a part of the Research Policy and Compliance team for the Harvard Stem Cell and Regenerative Biology (HSCRB) department. Under the direction of the Associate Director of Research Policy and Compliance, Manager will support the research of HSCRB faculty and the iPS Core Facility, which is a fee-for-service based core laboratory operated by the Harvard Stem Cell Institute. Manager will serve as the primary point of contact for inquiries regarding the use of human subjects, human material and data related to individual people in the highly regulated field of stem cell & regenerative biology.
Maintain a basic knowledge of laws, regulations, guidelines, policies relating to human subjects research, stem cell and regenerative biology, and biobanking; keep up with regulatory changes and adapt internal procedures accordingly;
Participate in the development and delivery of training and education about human research compliance throughout the department;
Facilitate communication between HSCRB labs and the Office of Technology Development (OTD) and the Office of Sponsored Programs (OSP) to establish contracts for the receipt or distribution of material from the labs;
Independently conduct compliance reviews of documents e.g. pre-submission funding proposals;
Independently plan, organize and manage all simple and some complex IRB and ESCRO applications and protocols for HSCRB labs and the iPS Core
Establish procedures for the maintenance of files to document compliance, implement procedures and maintain files accordingly;
Manage administrative and compliance related aspects of the iPS Core Facility including the intake of requests under the Core's service agreements, distributions for the Core's repository;
Liaise with other departments within the University such as the IRB, ESCRO, OTD and Office of the General Counsel (OGC).
Responsibilities may also include other general support for research compliance activities, based on the departmental and lab needs.
The FAS and the Department of Stem Cell & Regenerative Biology are committed to cultivating not only the diversity of our faculty, staff, and students but also in developing an inclusive culture that is vibrant, engaging and encouraging of innovation as well as intellectual debate. We believe creating and maintaining an inclusive workplace allows employees from all backgrounds and walks of life to achieve their fullest potential. We also believe an inclusive culture is one that accepts, values and views as strength the difference we all bring to the workplace. We encourage our community members to participate in our FAS Diversity Dialogues.
Salary Grade: 056
Union: 55 - Hvd Union Cler & Tech Workers
Bachelor's degree with at least 3 years' experience required. Experience in research administration, compliance, contract management or law . A combination of work experience and education in research administration, compliance, contract management or law will be considered.
Four or more years of relevant work experience preferred.
Excellent communication skills, with the ability to organize, write about, and discuss complex issues clearly
Demonstrated ability to take initiative and work both independently and as a team member
Experience managing multiple projects simultaneously with an ability to work well under deadlines
Prior experience working in a fast-paced academic research environment and particularly research compliance preferred
Scientific background not required but would be preferred.
Demonstrated proficiency in the MS-Office Suite of computer applications.
EQUAL OPPORTUNITY EMPLOYER: 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, or any other characteristic protected by law.
Internal Number: 53235BR
About Harvard University Faculty of Arts and Sciences
Harvard University is devoted to excellence in teaching, learning, and research, and to developing leaders in many disciplines who make a difference globally. The University, which is based in Cambridge and Boston, Massachusetts, has an enrollment of over 20,000 degree candidates, including undergraduate, graduate, and professional students. Harvard has more than 360,000 alumni around the world. The University has twelve degree-granting Schools in addition to the Radcliffe Institute for Advanced Study, offering a truly global education. Established in 1636, Harvard is the oldest institution of higher education in the United States.