IRB Analyst-IRB Department-40 Hrs/Week-Day Shift
St. Elizabeth's Medical Center is a member of Steward Health Care. As a member of Steward, St. Elizabeth's Medical Center pledges to: foster excellence in care; commit to those in need; affirm the value and dignity of life; exercise justice and responsibility for the common good; and advocate for the poor and disenfranchised.
Our mission finds expression and is animated by the core values of:
SERVICE to a diverse community
EDUCATION and leading edge research
MINISTRY rooted in ethical and religious principles
COMPASSION and caring for the whole person
Coordinates the daily activities of the IRB, including providing support to the Research Administration Director, IRB Manager, IRB Chair and IRB Members.
Responsible for ensuring IRB activities are conducted in compliance with research regulations, HIPAA and institutional and Steward-wide policies.
Performs administrative review and regulatory analysis of all IRB submissions, from SEMC and other Steward Health Care locations, for completeness, accuracy, and regulatory compliance.
Functions as a resource to research investigators and staff, providing instruction and guidance regarding the IRB review process.
II. Job Relationships:
Reports directly to the IRB Manager
Works closely with the Chair of the IRB
Functions as a liaison between the IRB Chair, IRB Members, investigators, research staff and administrative staff at St. Elizabeth’s and other Steward Hospitals.
Ability to effectively and pleasantly communicate with diverse populations within Steward Health Care.
III.A. Responsibilities/Essential Functions:
Performs a detailed analysis of all IRB submissions for completeness, accuracy, ethical and regulatory compliance
Provides instruction and support to investigators and research staff on the regulations, IRB review process and preparation of IRB applications and reports
Develops and implements IRB/HIPAA forms. Reviews and contributes to IRB policies and procedures.
Identifies and resolves potential problems with IRB submissions, prior to full board review
Determines the appropriate review process (expedited, exempt or full board review)
Demonstrates sound judgment, as well as analytical, organizational and time management skills
Provides technical support and guidance on regulatory matters at IRB meetings
Works collaboratively with other IRB staff in preparation of materials for review by the full board.
Documents IRB determinations in the drafting of comprehensive meeting minutes and correspondence to investigators, that effectively outline the concerns, rationale and technical questions of the IRB
Conducts evaluation of the investigator’s response to IRB concerns and determines the adequacy and completeness of the investigator responses, requesting additional material or information in order to address the concerns and advises as to whether the requirements for IRB approval have been met
Assists in the evaluation and acquisition of protocol tracking software. Interfaces with vendor on upgrades and modifications. Prime contact with vendor on all issues.
Documents the review process through complete and timely entries in the IRB online submission and protocol tracking system
Responsible for IRB record retention
Participates in identifying needs and makes recommendations in the operations of the IRB and IRB office
Works with Steward to develop and maintain research administrations websites.
Provides back-up support to the IRB Manager
Provides assistance and participates in facilitating a monthly clinical research coordinator meeting
Provides assistance in organizing and participates in all relevant institutional research educational activities related to human subjects protections and IRB operations
Assists in the identification and recruitment of new IRB committee members
Acts as a resource to other Steward hospital IRBs
[Text Wrapping Break]IV. Responsibilities/Non-Essential Functions:
Performance of any duties as requested by supervisor within the scope of this position.
Reports to IRB Manager
Collaborates with Director for Research Administration
Shall be accountable for having a firm foundation in the guidance and regulations that govern the inclusion of human subjects in research
Shall be accountable for maintaining confidentiality on all patient and research related data and for abiding all relevant governmental policies and procedures.
Accountable for abiding by all departmental and medical center policies and procedures
Accountable for assuring a safe environment for patients and research staff.
Accountable for following JCAHO, DPH, HIPAA, and IRB requirements
Minimum Education: Bachelor’s degree
Minimum Experience: 2-3 years in IRB office, IRB Administration, clinical research or other humans subjects protection-related job
Minimum skills/abilities: Basic knowledge of clinical research and familiarity with medical terminology
Excellent time management skills with ability to independently prioritize, organize and efficiently deal with multiple ongoing activities
Excellent communications and interpersonal skills and ability to pay attention to detail
Certification/Licensure: Certified IRB Professional is preferred.
Training: A working knowledge of federal regulations pertaining to research, International Conference on Harmonization GCP and HIPAA
MS word and MS windows and experience with computerized databases
Have the ability to make accurate and appropriate independent judgments and know when to refer issues to supervisor
Exceptional analytical ability