|
POSITION SUMMARY: Administers the activities of the BMC-Brighton and BMC-South Institutional Review Board ensuring compliance with federal, state and BMCHS Regulations governing human subjects in research. Ensures that the committee meets federal standards and oversee the IRB analyst(s). Acts as the primary resource to review and coordinate any human subject research that takes place at BMC-Brighton and BMC South Hospitals. This job supervises one IRB Analyst. Position: Manager, IRB Department: General Research Schedule: Full Time ESSENTIAL RESPONSIBILITIES / DUTIES:
Oversee protocol review process, including assigning primary reviewers, committee action reports, continuing review of approved protocols, and protocols to be conducted at affiliated institutions. Oversee and coordinate in the review of proposals meeting criteria for the central IRB, exempt and expedited protocols, humanitarian use device protocols and requests for emergency use of investigational products protocols. In consultation with the Chair and BMC legal Interprets and applies federal and state laws, regulations, institutional policies and guidelines to protect human subjects and to ensure institutional compliance. Prepare and administer assurances, IRB registration and/or other agreements in accordance with relevant government agencies and institutions, such as the Office for Human Research Protections (OHRP). Periodically review all policies and procedures currently followed in the IRB office to ensure that the IRB is operating in compliance with the Department of Health and Human Services (DHHS) and Food and Drug Administration (FDA). Follow up, as needed, to enforce policies and address non-compliance. As needed, draft new policies for review and approval. In consultation with the Director of Research, interact with legal counsel and government officials on IRB and human research issues. Provide pertinent information to those preparing research proposal applications and consent documents; review and recommend modifications to submission and provide information on requirements for conducting research involving human subjects to SEMC staff and affiliated institutions. Oversee and develop procedures and agreements for BMC Brighton/South IRB review of research protocols to be conducted at other BMC hospitals, with guidance as needed from Director. Recruit and recommend new members to serve on the IRB and provide necessary information to new members on institutional review requirements based on policy, regulation, guidelines and ethical standards, which govern IRB activities. Prepare memorandums and letters for the IRB chair to committee members and investigators.
Oversee the day-to-day functions of the IRB office: Supervise one IRB Analyst, responsible for hiring, training, and evaluating IRB staff; establish work priorities and deadlines. Assist the Director in the annual budget process, maintenance of the IRB budget, and monitoring spending.; supervise the maintenance and updating of IRB database.
(The above statements in this job description are intended to depict the general nature and level of work assigned to the employee(s) in this job. The above is not intended to represent an exhaustive list of accountable duties and responsibilities required). JOB REQUIREMENTS EDUCATION:
CERTIFICATES, LICENSES, REGISTRATIONS REQUIRED:
EXPERIENCE:
2 years of experience working as an Analyst in an IRB required. 2 years of managerial experience, preferably in a research, academic or medical research environment preferred
KNOWLEDGE, SKILLS & ABILITIES (KSAs):
Ability to understand the role and function of the IRB in a medical and research setting, IRB regulations, federal and state laws, guidelines and ethical standards for the use of human subjects in research. Ability to understand research protocols, the clinical trial process and medical and clinical terminology. Ability to maintain confidentiality. Ability to work on multiple projects simultaneously.
Verbal and written communication skills; interpersonal/human relations skills; organizational, managerial and supervisory skills; and computer literacy
Equal Opportunity Employer/Disabled/Veterans
|
Boston Medical Center
Mar 31, 2025