- A Bachelor's degree in a scientific/technical field, with at least three years of experience related to research/regulatory compliance issues (e.g., human or animal subjects, safety, etc.).
- Familiarity with complex regulations related to highly sensitive research, data privacy laws, Federal Cybersecurity Requirements, and data privacy laws covering health care-related data.
- Working knowledge of the Microsoft Office suite.
- Familiarity with a university environment and general familiarity with research activities such as research grants and contracts and the Federal government strongly preferred.
- Expert communication skills - able to turn complicated federal mandates and requirements into manageable, user-friendly means of compliance.
- Master's degree in a scientific/technical field is a plus.
- Knowledge of research activities such as research grants and contracts and the Federal government.
- Creative problem-solving and willingness to facilitate compliance while maintaining excellent working relationships across the university.
- Relevant experience (e.g., working in a research compliance office, a sponsored programs office, or related field) in the implementation of federal compliance regulations.
- Supporting the implementation of compliance program elements, including reviewing research regulations for any university-wide impact, especially in the context of highly regulated data research and ICoMP.
- Developing institutional policies, procedures, guidelines, and programs that enable the conduct of research while ensuring compliance with regulatory requirements surrounding highly regulated data.
- Provide visible guidance and support for faculty - e.g., departmental presentations and one-on-one consultations - in developing data management plans and data use agreements for projects that include regulated data.
- Developing, coordinating, and providing guidance for a multifaceted educational and training program that focuses on the elements of the compliance program, and seeks to ensure that all appropriate employees and managers are knowledgeable about pertinent policies and federal and state standards for highly regulated data.
- Coordinating internal compliance review and monitoring activities, including periodic reviews of policies and programs for highly regulated data research.
- Staying abreast of evolving requirements pertaining to research administration and compliance legislation, regulation, and policies.
- Participating in investigation of matters related to compliance, including designing and coordinating internal investigations (e.g. with RMAS, School units, or OGC) and any resulting corrective action.
- Other duties as assigned.
- 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.
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Regulated Data Compliance Officer - Cambridge, United States - Harvard University
Description
Basic QualificationsCandidates MUST meet the following basic qualifications in order to be considered for this role:
Additional Information
Harvard University supports a hybrid workplace model which will actively support some remote work. Specific days and schedules for on-site work and remote work will be discussed during the interview process. Please note hybrid workers must reside in a state where Harvard is registered to do business (CA, CT, GA, IL, MA, MD, ME, NH, NJ, NY, RI, VA, VT, and WA).
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.
Position Description
Primary Responsibilities
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.
Job Summary
Reporting to, and working under, the direct supervision of the University Research Data Officer, the Regulated Data Compliance Officer (RDCO) works closely with various OVPR and other stakeholders to meet the goals and aims for supporting research that involves highly regulated data. Supports school research compliance departments in complying with federal, state, and other regulations and laws in relation to highly sensitive research data. Works with research compliance staff to ensure that regulated data research reporting requirements are satisfied within the newly established Institutional Compliance Management Program (ICoMP). Completes compliance related tasks in support of the office, including but not limited to coordinating with as well as representing the OVPR in committee meetings; reviewing and/or completing internal or external forms for regulated data compliance-related functions; assisting in the development and management of regulated data research compliance policies and procedures; assisting in the development and implementation of training for individuals and groups working with highly regulated data through workshops, websites, and other venues as appropriate. Additionally, the RDCO works across schools and directly with faculty and department research administrators to support preparation of Data Use Agreements (DUAs) prior to submission to Office of Sponsored Programs for negotiation.
The RDCO works closely with advisory committees, administrative units within the schools (e.g., Sponsored Programs Administration Offices, Compliance Units, Human and Animal Subject Protection Programs and Committees, Research Integrity Officers) as well as central units such as the Office of Sponsored Programs (OSP); Office of the General Counsel (OGC); Risk Management & Audit Services (RMAS), HU Information Technology (HUIT), Harvard Global Services; Office of Environmental Health, Safety and Emergency Management, etc.
RDCO promotes research compliance by working directly with committees, central and school level offices, and researchers in the preparation of and assessment of project specific regulatory requirements; and serves as a subject matter expert and point of contact to university personnel for advice, resources, education, and coordination for research involving highly regulated data. The incumbent acts as subject matter expert staff person for specific compliance committees.
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:
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.