Regulated Data Compliance Officer

Details

Posted: 22-Feb-24

Location: USA - MA - Cambridge

Type: Full-time

Salary: Open

Categories:

Administrative/Support
Staff/Administrative

Internal Number: 64187BR

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.

Position Description

Primary Responsibilities

• 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.

The RDCO must possess the ability to operate independently and with minimal supervision, exercising excellent judgment. The RDCO must possess the ability to work well with a wide variety of high-level constituents, with excellent written and oral communication skills. Strong attention to detail and the ability to review, summarize, and analyze complicated written materials is a must. Must be able to handle highly complex and confidential information with discretion.

Basic Qualifications

Candidates MUST meet the following basic qualifications in order to be considered for this role:

• 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.).

Additional Qualifications and Skills

• 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.

The successful applicant must be able to work independently, build collaborative teams with stakeholders, and be innovative and willing to facilitate compliance while maintaining excellent working relationships, have expert communication skills, and be eager to turn federal mandates and requirements into manageable, user-friendly means of compliance. Organized and detail-oriented with a proactive attitude. Ability to work on multiple projects effectively. Experience with Harvard financial and administrative applications preferred.

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.

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