Research Compliance/Program Administrator (IRB, HRPP & FCOI)

Overview

Under the supervision of the Director, Research Compliance / Assurance & Programs the Research Compliance / Program Administrator ( (IRB / HRPP & FCOI) is responsible for ensuring Joslin’s IRB / Human Subject Protection Program (HRPP) and Research Financial Conflict of Interest (FCOI) Program adheres to federal, state and local regulations as well as institutional policy.

The Administrator participates in the oversight of these programs along with performing the day-to-day program specific responsibilities and processes.

As a health care organization, we have the responsibility to do everything in our power to care for and protect our patients, our colleagues and our communities.

We require that all staff be vaccinated against influenza (flu) and COVID-19 as a condition of employment.

Responsibilities

Institutional Review Board (IRB) / Human Research Protection Program (HRPP) :

• Under the oversight of the Director, Research Compliance / Assurance & Programs administers the institution’s Human Research Protection Program (HRPP) including the Institutional Review Board / Committee on Human Studies (IRB / CHS).
• Reviews and manages all protocol applications and study material submitted to assure that all requirements for initial and / or continuing review as required by the applicable regulations and policies are met prior to consideration by the Committee.

For selected protocols, provides guidance to investigators and study staff.

• Determines level of review required (full / expedited) and coordinates the process of the proper review by the committee.
• Makes human subject research and protocol exception determinations.
• Reviews adverse event reports and determines whether routing to physician Chair of IRB / CHS (or designee) and / or further action is warranted.
• If eligible, as determined by the Institutional Official, may serve as an Alternate Voting Member of the Committee for the Director, Research Compliance / Assurance & Programs and performs expedited reviews / approvals for minor changes to previously approved protocols and additional protocol material (i.

e. addition of study staff, recruitment material, and administrative changes to protocols and / or consent forms).

• Trains and assists staff in the review process of the Committee and eIRB system and in achieving appropriate actions as requested by the committee.
• Advises staff on the appropriate practices in conducting human subject research at the institution and helps interpret and clarify federal regulations and institutional policies on human subject.
• Composes letters and memos on behalf of the Committee, coordinating the actions of the Committee, corresponding with staff for the Committee.
• Responsible for all meeting preparation and post-meeting activities.
• Maintains all records (databases and physical records) for the Committee and assures they are accessible upon request to Committee members and authorized regulatory agencies.
• May present selected sessions / modules at the institution-wide education program to all staff involved in human subject to meet regulatory requirements.

Assists in curriculum planning.

• Responsible for the non-scientific aspects for the routine not-for-cause monitoring / auditing of human subject research to ensure compliance federal, state and local regulations as well as institutional policy.
• Takes part in the process of the review for requests for cede review / reliance to an external IRB / sIRB for studies and for studies that Joslin is serving as the reviewing for.

Financial Conflict of Interests (FCOI) :

• Participates in all administrative aspects required to ensure compliance with the federal FCOI regulations and institutional FCOI policy.
• Solicitates the required disclosures from identified Investigators.
• Conducts initial review of submitted disclosures and determines level of review needed.
• Coordinates the process of the review of disclosures and takes part in the review.
• Responsible for the correspondence of the receipt, review and resolution of the required disclosures to Investigators and Research Administrators.
• Maintains all required FCOI records and documentation (i.e. disclosures, outcomes of reviews, training information).

Qualifications

• Bachelors Degree in a related area or two or more years related experience in an academic research environment (preferably in health care area).
• 2-3 years of experience in an academic research environment, preferably working with IRB and / or within a research setting with a strong preference for regulatory oversight.
• Certified IRB Professional (CIP) or Certified IRB Manager (CIM) is preferred (or eligible for certification).
• Current knowledge of federal, state, and local regulations pertaining to the conduct of research and research compliance, such as DHHS, OHRP and FDA.
• Outstanding written and oral communication skills
• Excellent organizational and interpersonal skills. Strong problem solving skills
• Ability to perform multiple tasks with a high level of accuracy and attention to detail
• Ability to work independently in a team-oriented environment
• Ability to meet deadlines with competing priorities
• Ability to exercise sound judgment and initiative in collecting technical information from a wide variety of sources
30+ days ago