Regulatory Affairs Operations Coordinator Job Vacancy in Harvard University Boston, MA – Updated today

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Company Name : Harvard University
Location : Boston, MA
Position :

Job Description : Job-Specific Responsibilities
Harvard Catalyst | The Harvard Clinical and Translational Science Center facilitates clinical and translational research at 30 Harvard schools and Academic Healthcare Centers by educating and training investigators, providing tools and technologies that enable their research, and bringing diverse communities of investigators together to accelerate the pace of human investigation.

Reporting to the Director, Regulatory Affairs and Operations (Director) the Regulatory Coordinator (RC) works closely with the Director to support the development of Harvard Catalyst’s Regulatory Foundations, Ethics, and Law Program and SMART IRB. The RC performs a wide range of complex and sometimes confidential duties in support of the goal of lowering barriers to inter-institutional research.
The RC has three major areas of responsibility: (1) skilled administrative coordination (2) administrative operations and project coordination for the Program (3) research and special projects.
Provide skilled administrative coordination support to the Director.
Manage complex calendars and related logistics by triaging a high volume of scheduling, travel arrangements, expense reporting, and related logistics to assure the Program and SMART IRB meet deadlines and deliverables.
Assist the Director in developing agendas for high-level meetings and attend meetings as requested to take minutes and capture action items.
Review, redline, and proofread documents such as reports, agreements and presentations.
Draft high-level correspondence such as email, and other communications.
Create PowerPoint presentations with infographics for local and national presentations.
Collect Program metrics with assistance of the Regulatory Officers.
Assist the Director and the SMART IRB Associate Director in maintaining initiatives and deliverables.
Provide meeting support and project coordination to the CTSC Regulatory Program, including support to SMART IRB, Central Administration, and Regulatory Subcommittees comprised of high-level directors and managers; and maintain existing tools and deliverables as needed:
Coordinate and schedule all meetings, space reservations, catering, A/V, and parking in support of the 12-15 subcommittee monthly meetings.
Set up for and attend two in-person regulatory meetings a year as well as monthly virtual subcommittee meetings; take minutes, receive and distribute documents, and compile summaries that may include project plans, target dates, and team responsibilities.
Assist in event and project planning in coordination with the Regulatory Operations Officers.
Maintain and draft content for the Program’s policy and procedure manual.
Oversee and maintain all Program and SMART IRB listservs and serve as the primary owner of the Regulatory Program email account, triaging and responding to requests for information, assistance, tools, or services.
Support maintenance of and updates to the Harvard Catalyst website on behalf of the Regulatory Program; this includes but is not limited to quality assurance of existing tools and resources (e.g. Research Participant Resources), updating Program and subcommittee contact directories, and facilitating and tracking Program and SMART IRB marketing/outreach efforts for events, resources, and services (online, email, etc.).
With direction and authorization from the Director, conduct ad-hoc and long-term research and complete special projects.
Provide project management support in short and long-term special projects by researching, recommending, and initiating action plans.
Conduct ad-hoc and long-term research by examining current state and federal laws and regulations, national best practices across other CTSAs, CTSA working group reports, practices and policies of non- CTSA clinical research centers, and policies and guidance documents of the pan-Harvard AHCs. Research projects may include policy analysis, document comparison, and literature reviews.
Other duties as assigned.
Basic Qualifications
3 or more years providing administrative or executive support and project coordination, in the area of research administration, academia, healthcare, or related field.
Additional Qualifications and Skills
College degree preferred or equivalent of education plus experience in an office environment.
Successful candidates will have well-developed interpersonal and communication skills with experience providing complex administrative support in a high-profile, very fluid environment, with tact and diplomacy on a range of issues, many of which are confidential in nature.
Ability to work with cross-institutional teams and with a variety of special/ongoing projects and diverse constituencies.
Excellent organizational and writing skills.
Excellent computer skills, including knowledge of Microsoft Office, Outlook, and PowerPoint.
Ability to prioritize work in an environment with multiple and conflicting interests.
Expertise with scheduling.
Additional Information
This is a term appointment, with the end date of April 30, 2023, with the possibility of renewal contingent on funding.

This Staff role may start as a remote position due to the COVID-19 pandemic and while restrictions are still in place. The current remote nature of this role is considered temporary and may change as the University continues to evaluate options. While we continue to monitor the evolving COVID-19 guidelines, local on-campus work may be expected for some roles. Harvard Medical School does support flexible schedules, subject to individual departments’ business needs.

Harvard requires COVID vaccination for all Harvard community members. Individuals may claim exemption from the vaccine requirement for medical or religious reasons. More information regarding the University’s COVID vaccination requirement, exemptions, and verification of vaccination status may be found at the University’s “COVID-19 Vaccine Information” webpage: http://www.harvard.edu/coronavirus/covid-19-vaccine-information/.

Please note that we are currently conducting a majority of interviews and onboarding remotely and virtually. We appreciate your understanding.

Harvard University offers an outstanding benefits package including:
Time Off: 3 – 4 weeks paid vacation, paid holiday break, 12 paid sick days, 12.5 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, incredibly affordable classes directly 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.

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Job Function
General Administration, Research
Location
USA – MA – Boston
Job Code
403134 Coordinator I
Sub-Unit
–
Department
Clinical and Translational Science Center
Time Status
Full-time
Salary Grade
054
Union
55 – Hvd Union Cler & Tech Workers
Appointment End Date
30-Apr-2023
Pre-Employment Screening
Identity
Schedule
35 hrs. per week | Monday – Friday | 9:00 am – 5:00 pm
Commitment to Equity, Diversity, Inclusion, and Belonging
We are committed to cultivating an inclusive workplace culture of faculty, staff, and students with diverse backgrounds, styles, abilities, and motivations. We appreciate and leverage the capabilities, insights, and ideas of all individuals. Harvard Medical School Mission and Community Values
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.

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