About the Organization     
The mission of Fenway Health is to enhance the wellbeing of the lesbian, gay, bisexual and transgender community and all people in our neighborhoods and beyond through access to the highest quality health care, education, research and advocacy.

In 2013, Fenway Health announced a historic partnership with AIDS Action Committee that allows the two organizations to work more closely together and improve delivery of care and services to people living with HIV/AIDS.

AIDS Action Committee of Massachusetts is a leader in the fight against HIV/AIDS, advocating at the city, state, and federal levels for fair and effective AIDS policies, conducting cutting edge HIV prevention programs, and providing health and wellness services to people already living with HIV. Founded in 1983, AIDS Action is New England’s largest AIDS service organization.  

Description     
Reporting to the Director of Clinical Research, the Manager of Research Integrity and Compliance is responsible and accountable for the oversight and management of research compliance activities including human research protection, conflict of interest and quality assurance. The Manager of Research Integrity and Compliance interprets and applies federal and state laws, regulations, institutional policies, and guidelines and develops research compliance policies and procedures in response to rapidly evolving state and federal laws and regulations.   

Representative Duties

1. Implement comprehensive research compliance program for The Fenway Institute.

  • Leads the development and interpretation of policies and procedures for TFI and the organization to ensure compliance with all relevant regulations.
  • Represent TFI as primary contact for research regulatory issues with state and federal regulatory agencies, as well as with other research institutions.  Interact and maintain effective working relationships with federal and state regulatory agencies for guidance, compliance reporting, inspections and /or audits.
  • Develop and implement training for research conducted with human subjects, research compliance, and the responsible conduct of research.
  • Providing direction, training, and consultation to investigators and research staff regarding current issues and ethical concerns.
  • Manages financial conflict of interest reporting in compliance with TFI policy.
  • Support the activities of the Research Misconduct and Conflict of Interest committees.
  • Maintains accurate and comprehensive records of research compliance activities and other reports as necessary to comply with appropriate regulations.
  • Provides consultation services and acts as liaison to faculty, staff and affiliate investigators and research staff on the application and implementation of the federal regulations, state laws, and institutional policies for human subjects’ research.
  • Monitors and analyzes current and new regulations affecting human subjects research integrity, data security and privacy requirements.
  • Provides technical assistance to protocol teams from site activation through study closure.

2. Responsible for quality assurance activities for The Fenway Institute.

  • Responsible for developing a culture of regulatory compliance through training, education, audits and other monitoring processes.
  • Develop annual quality assurance monitoring planning in consultation with Director and IRB.
  • Monitor approved studies for compliance with regulations, IRB approved protocol and institutional policies.
  • Identify through monitoring and risk assessment potential areas of non-compliance and establish policies to mitigate research risk and improve compliance with regulations and institutional policies.
  • Conduct monitoring visits for all Investigator-held INDs.

3. Manages human subject protection program.

  • Manage operations for the Fenway Health Institutional Review Board and serve as the administrative interface between the IRB, TFI administration and research community.
  • Provide regulatory/ethical technical assistance and consult to IRB members, researchers, and research coordinators on human subject protection.
  • Responsible for the development, implementation and management of IRB policies and procedures and the related administrative operations of IRB office in order to comply with all federal and state regulations.
  • Conduct preliminary review of all research protocols and submissions to ensure research studies involving human subjects are in compliance with institutional policies and state and federal regulations.
  • Responsible for IRB minutes, correspondence and recordkeeping.
  • Provides professional support to IRB by preparing agendas for meeting, attending meetings to act as an information resource, and assigning reviewers to particular proposals.
  • Prepares presentation materials and delivers educational programs on regulatory and ethical compliance in research to the IRB and research community.

Position Requirements

Education:
Bachelor’s Degree in related field.
Master’s or doctoral level degree in related field highly desirable.

Experience/Other Requirements:
3-5 years related work experience in human subject research.
Familiarity with quantitative and qualitative research methods.
Excellent knowledge of federal and state regulations pertaining to research on human subjects.

Supervisory Responsibility:
Supervises staff engaged in compliance and quality assurance activities as needed.