The Research and Data Compliance Coordinator will work as part of the Department of Health Care Policy (HCP) Compliance Office. The Compliance Office serves as a departmental resource for facilitating and supporting the research conducted at the department by ensuring appropriate data security and compliance in accordance with state and federal regulations and university policies governing health care data and human subjects research. This position requires understanding and interpreting relevant policies and reliably carrying out related procedures to ensure departmental compliance related to acquiring and maintaining research data in support of sponsored research activities. This position will also provide research and administrative support for several HCP faculty.
The compliance responsibilities of the position will include assisting the Director of Compliance in the day-to-day management of the Compliance Office email inbox and the University Institutional Review Board (IRB) and data use agreement (DUA) management systems. Tasks may include but are not limited to: preparation of department training materials, draft reports and/or guidance for staff, faculty, and students, assist with training and outreach programs (group, one-on-one), ensure HCP Compliance workflow is maintained in a timely manner, and effectively communicate with the contracts team and IRB office and other affiliates collaborating with the HCP Compliance Office. The position will be responsible for the compliance responsibilities of the department-wide onboarding process, data destruction, and providing support to researchers with data applications and data management plans.
They will stay abreast of changes in federal, state, and industry policy standards regarding acquired research data. The Research and Compliance Coordinator will work with the Data Compliance Officer to identify trends to improve program effectiveness. This person will serve as the department expert on IRB policies and procedures with a focus on the IRB application process. This person will provide support to faculty, staff, and students in the assembly and submission of IRB applications through the Electronic Submission Tracking and Reporting (ESTR) system. They will remain abreast of ongoing compliance activities in order to disseminate new information and provide departmental support.
In support of the research activities of assigned faculty, this position will be provide a combination of administration and research-related duties including assistance with data acquisition and compliance procedures, coordinating project-related meetings and travel, planning and preparation for meetings and events, independently composing complex and sensitive correspondence, reports and documents, and taking on ad hoc projects as needed.
Harvard offers an outstanding benefits package including:
Time Off: 3 - 4 weeks paid vacation, paid holiday break, 12 paid sick days, 11.5 paid holidays, and 3 paid personal days per year.
Medical/Dental/Vision: We offer a variety of excellent medical plans, dental & vision plans, all coverage begins as of your start date.
Retirement: University-funded retirement plan with full vesting after 3 years of service.
Tuition Assistance Program: Competitive tuition assistance program, $40 per class at the Harvard Extension School and discounted options through participating Harvard grad schools.
Transportation: Harvard offers a 50% discounted MBTA pass as well as additional options to assist employees in their daily commute.
Wellness options: Harvard offers programs and classes at little or no cost, including stress management, massages, nutrition, meditation, and complementary health services.
Harvard access to athletic facilities, libraries, campus events and many discounts throughout metro Boston.
The Harvard Medical School is not able to provide visa sponsorship for this position.
Salary Grade: 055
Union: 55 - Hvd Union Cler & Tech Workers
5 or more years of related work experience, preferably in human subjects research environment including independent management of IRB protocols. Higher education may count toward years of experience.
Bachelor's degree preferred. Must demonstrate strong organizational, administrative, time management, and communication (both verbal and written) skills and the ability to work under pressure in a fast-paced, developing organization with facility to interact professionally at all times. Strong knowledge of Microsoft Office applications and facility with learning new computer applications. Ability to handle sensitive and confidential information and to prioritize multiple tasks, meet deadlines, and organize complex projects. Must be detail-oriented with strong problem-solving skills. The ideal candidate is expected to work both independently and have the ability to work with a variety of stakeholders to steward complex processes to completion. The candidate needs to be a flexible and quick learner and capable of working independently with multiple and conflicting priorities and frequent deadlines. They should be able to anticipate and resolve problems and communicate updates to supervisor and faculty on the status of projects. Familiarity with sponsored research administration and Harvard compliance systems such as ESTR and Agreements a plus.
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: 50092BR
About Harvard University Medical School
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.