Deadline: Open until filled.

Contact
Kimberley Serpico

617-432-7434

Links Read the full call

Job Code: 43326BR

Duties & Responsibilities

The Office of Regulatory Affairs & Research Compliance (ORARC) ensures the quality and integrity of research conducted at the Harvard T.H. Chan School of Public Health. ORARC works in conjunction with various Harvard departments in areas such as conflicts of interest, data and information security, research integrity, intellectual property, animal research and biological safety.
 
A major unit within ORARC is the Office of Human Research Administration (OHRA), which is a comprehensive administrative office designed to review, approve, assist, and oversee all human research projects conducted by Harvard T.H. Chan School of Public Health, Harvard Medical School, and Harvard School of Dental Medicine faculty members and students. OHRA is the primary component of Harvard Longwood Medical Area’s Human Research Protection Program (HRPP). Within OHRA there are two major units: IRB Operations and Quality Improvement Program.

Under the direction of the Office of Human Research Administration (OHRA) Managing Director and reporting directly to the Assistant Director of IRB Operations, the incumbent is responsible for performing administrative review for assigned departments within the Harvard Longwood Medical Area Schools (Harvard T.H. Chan School of Public Health, Harvard School of Dental Medicine, and Harvard Medical School).  The incumbent is required to work independently with minimal supervision in selecting and applying established regulations and procedures appropriately, and in determining when to refer situations/issues to Directors.

  • Serve as a member of the Harvard Chan School and Harvard Faculty of Medicine IRB panels.
  • Serve as a designated reviewer with the authority to make not-human-subjects research and/or exemption determinations; approve non-exempt minimal risk research using the expedited review procedure; approve minor changes in approved research not otherwise eligible for expedited review; review reportable new information; prepare protocols for monthly convened IRB meetings.
  • Serve as primary contact for assigned Departments/Divisions: provide guidance, recommendations, best practices, and explanations to Harvard Longwood Medical Area School faculty, staff, and students in a timely manner.
  • Identify inconsistencies, gaps in process, and areas for improvement in process/practice, and present them during review team meetings for discussion; facilitate resolution.
  • Update and maintain Harvard’s online submission system: Electronic Submission, Tracking, and Reporting (ESTR), and any applicable internal tracking logs.
  • Draft, edit and prepare correspondence, reports, study management tools, and other material using word processing, spreadsheets and/or databases.
  • Participate in IRB-related QA/QI and educational activities as needed.

PLEASE NOTE: The finalist for this position must obtain the Certified IRB Professional (CIP) designation or be CIP eligible. If the successful applicant does not already possess the CIP designation, s/he will be required to obtain it within 1 year of start date.
 
PLEASE NOTE: Candidates that are invited for an in-person interview will be required to review one IRB application. This application will be provided to candidates at the time that the interview is scheduled (in advance of the in-person meeting). Candidates should be prepared to discuss the application, and whether it meets the approval criteria, during the in-person interview.

Basic Qualifications

  • Bachelor's Degree required.
  • 3+ years of directly related experience required.

PLEASE NOTE: The finalist for this position must obtain the Certified IRB Professional (CIP) designation or be CIP eligible. If the successful applicant does not already possess the CIP designation, he/she will be required to obtain it within 1 year of start date.

PLEASE NOTE: Candidates that are invited for an in-person interview will be required to review one IRB application. This application will be provided to candidates at the time that the interview is scheduled (in advance of the in-person meeting). Candidates should be prepared to discuss the application, and whether it meets the approval criteria, during the in-person interview. 

Additional Qualifications

  • Master's Degree preferred.
  • Solid working knowledge of federal and state regulations governing human research and Good Clinical Practice guidelines strongly preferred.
  • Strong analytical written and oral communication skills, and experience multi-tasking in a busy office environmental while maintaining superior customer service preferred.
  • Experience using multiple technical applications including word processing, database management, and spreadsheets, graphics and presentation software, electronic calendar, email, and other technical applications preferred.
  • Experience maintaining strict standard of confidentiality preferred.

Additional Information

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 complimentary health services.
  • Harvard access to athletic facilities, libraries, campus events and many discounts throughout metro Boston.

Join the Harvard T.H. Chan School of Public Health to support our mission of health research and education, and to be a part of the oldest institution of higher learning in the country!

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 or any other characteristic protected by law.

human subjects research job opportunity