RESEARCH REGULATORY ADMINISTRATOR, School of Medicine, Framingham Heart Study

Tracking Code22500558510412Job Description

The Framingham Heart Study Center is seeking a Research Regulatory Coordinator (RRC) to support and ensure compliance for their portfolio of research studies. The main functions of this position are to manage the Framingham Heart Study Center’s adherence to research compliance and serve as a liaison between the FHS research teams and research compliance offices (e.g. IRB, CRRO, OHRA, Research Compliance). This position also provides administrative support to study leadership and FHS research review committees.

This position is hybrid (remote and onsite). FHS has two onsite offices: Boston and Framingham.

This position will work collaboratively with a variety of personnel at all levels, including researchers and faculty and study team members of FHS and collaborating institutions. Works cooperatively with the BMC-BUMC Institutional Review Board (IRB), Office of Human Research Affairs (OHRA), and the NHLBI (study sponsor).

Essential Responsibilities/Duties

Regulatory Compliance and Adherence

• Identify and resolves issues with OHRA compliance, including the management of IRB protocols and keeping principal investigators aware of any problems related to their protocols.
• Gather and maintain information on IRB approvals and ensures appropriate sign-off for research data and sample sets, given the status of informed consent and data release requirements.
• Manage and track regulatory documentation, investigators' financial conflict of interest disclosures (COI, fCOI), institutional authorization agreements (IAA), and other compliance documentation.
• Provide guidance, to staff and investigators, on the FHS informed consent process and other research activities regulated by the OHRA/CRRO/IRB offices. Describe these compliant procedures in IRB documentation.
• Oversee the implementation of policies and procedures to ensure compliance with Federal, State, and local regulations governing the protections of human subjects.
• Coordinate IRB adherence and planning with other Boston University offices, compliance committees, and external collaborating teams/institutions.

Protocol Management

• Prepare and coordinate submission of new protocols, amendments of existing protocols, annual continuing review reports, final/closure reports, reports of deviations and adverse events for IRB review and approval, and monitors adherence to IRB protocols.
• Provide guidance with regard to research compliance and provide administrative support to study leadership and review committees, in order to meet contract deliverables.

Research Administration

• Serve as primary source of IRB regulatory and ethical guidelines for FHS investigators, managers, and staff.
• Represent, as necessary, the Framingham Heart study with collaborating institutions, sponsors, and regulatory agencies with regard to research compliance.
• Attend leadership and committee meetings to serve as a source of regulatory and ethical guidelines for FHS research.
• Provide general administrative support to study leadership, when needed, and FHS research review committees on an ongoing basis.

Required Skills

Master's degree in Public Health or administrative related field, preferred, 3-5 years of related experience. Or, Bachelor's degree required with 5-8 years of related experience.

Please note all newly hired staff and faculty, will need to be in compliance with Boston University’s COVID-19 Vaccination and Booster Requirement within 30 days of date of hire. You must upload your vaccine documentation or request a medical or religious exemption (instructions). For further information on the University’s response to COVID-19, please visit the Back2BU site.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, physical or mental disability, sexual orientation, gender identity, genetic information, military service, pregnancy or pregnancy-related condition, or because of marital, parental, or veteran status. We are a VEVRAA Federal Contractor.

Job LocationFramingham, Massachusetts, United StatesPosition TypeFull-Time/Regular