IRB Manager

I. Position Function:

Directs and administers the activities of the SEMC Institutional Review Board ensuring compliance with federal, state and Steward Regulations governing human subjects in research. Acts as the primary resource for any human subject research for the Steward Health Care

II. Job Relationships:

IRB chair and members, researchers (including investigators at all levels, physicians, postdoctoral fellows), government agencies, sponsors, research nurses, external institutions that do not have an IRB, administrative managers and assistants, grants, compliance and contracts management.

III. Authority:

Has the authority to direct and oversee the Institutional Review Board (IRB) program at SEMC and to support and oversee the other Steward IRB's within the system

Has the authority to develop SEMC IRB policies and procedures, and review and make recommendations for other Steward IRBs.

Has the authority for hiring and supervising IRB staff, training and ongoing evaluation, maintaining time records and other personnel issues.

IV. A. Responsibilities/Essential Functions:

1.) "Provides superior customer service to internal and external clients, customers,

and patients as referenced in the Service Excellence Standards."

Interpret and apply federal and state laws, regulations, institutional policies and guidelines to protect human subjects and to insure 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).

Interact with legal counsel and government officials on IRB and human research issues.

Provide information on requirements for conducting research involving human subjects to SEMC staff and affiliated institutions.

Oversee and develop procedures and agreements for SEMC IRB review of research protocols to be conducted at other Steward hospitals.

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.

Monitor IRB committee membership to insure compliance with the proper number and varying backgrounds.

Coordinate a comprehensive training session for IRB members and investigators at least annually.

Provide pertinent information to those preparing research proposal applications and consent documents; review and recommend modifications to submissions.

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.

Oversee protocol review process, including assigning primary reviewers, committee action reports, continuing review of approved protocols, and protocols to be conducted at affiliated institutions.

Provide oversight of preparation for committee meetings, including agenda and minutes.

Prepare memorandums and letters for the IRB chair to committee members and investigators.

Responsible for protocol tracking software and the Research Administration websites

Keep Committee members apprised of their responsibilities regarding conflicts of interest.

Review all miscellaneous and delinquent protocol files and determines appropriate action.

Participate in national organizations and workshops for IRB professionals.

Direct and supervise the functions of the IRB office; responsible for hiring, training, and evaluating IRB staff; establish work priorities and deadlines; maintain the IRB budget and monitor spending; approve expenditures and requisitions; supervise the maintenance and updating of IRB database.

B. Responsibilities/Non-Essential Functions:

Performs other related duties that may be requested by the Director of Research Administration, IRB Committee Chair, and Research/Human Subjects Committee.

V. Reporting Requirements:

Reports to the Director of Research Administration.

VI. Accountability:

Shall be accountable for abiding by all relevant IRB and hospital policies and procedures.

VII. Qualifications:

Minimum Education:

Associates/Bachelor's degree.

Minimum Experience:

Three years of managerial experience, preferably in a research, academic or medical research environment.

Minimum skills/abilities:

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.

Certification/Licensure: IRB Certified preferred

Equal Opportunity Employer/Disabled/Veterans