IRB Specialist - Institutional Review Board
About the position
The IRB Specialist is primarily responsible for the management of a caseload of applications submitted for IRB review and demonstrates sound judgment, as well as analytical, organizational, and time management skills. Serves as a critical link between and is an expert resource for the Mayo research community (principal investigators and other study personnel), the Mayo's Office for Human Subjects Protection, and the Mayo IRB members; is knowledgeable about the federal and state regulations governing human subject research, and related institutional policies and procedures; continuously interprets and applies these requirements to human subject research proposals and ongoing research activities; performs a detailed analysis of all applications submitted for IRB review; manages the disposition of items submitted electronically for IRB review. This includes assessments of completeness, accuracy, and level of review required. Applies strong organizational skills and effective teamwork skills to manage a large volume of submissions, deadlines, and customer expectations; completes critical and comprehensive review of submissions, seeks clarification or alteration of the submission from Mayo researchers, and makes independent determinations or presents recommendations to the convened IRB. Serves as a voting member of the convened IRB and a designated Expedited Reviewer to review and approve non-exempt minimal risk research using expedited review procedures; provides technical support and guidance on regulatory matters during convened IRB meetings; conducts expedited reviews, documents application-specific findings and generates investigator notifications regarding the outcome of the review. Exercises the authority to make not-human subjects research and exempt determinations; responsible for conducting evaluations of investigator's response to identify potential issues for IRB reviewers and advise as to whether the requirements for IRB approval have been met. In partnership with the IRB Chairs, is responsible for managing the pre-meeting, meeting and post-meeting activities of the convened IRB. This includes agenda management, and meeting facilitation and documentation. Provides guidance to IRB Administrative Assistants, in support of efficiency and effectiveness of IRB operational activities and drafts, edits and prepares correspondence and notification letters using databases. Participates in the orientation and training of IRB personnel, including peers. Assists with the orientation of new IRB members and actively participates in the training of new nonscientific IRB members and participate in IRB-related quality and educational activities as needed.
Responsibilities
• Management of a caseload of applications submitted for IRB review.
• Serves as a critical link between and is an expert resource for the Mayo research community, the Mayo's Office for Human Subjects Protection, and the Mayo IRB members.
• Interprets and applies federal and state regulations governing human subject research, and related institutional policies and procedures to human subject research proposals and ongoing research activities.
• Performs a detailed analysis of all applications submitted for IRB review.
• Manages the disposition of items submitted electronically for IRB review, including assessments of completeness, accuracy, and level of review required.
• Completes critical and comprehensive review of submissions, seeks clarification or alteration of the submission from Mayo researchers, and makes independent determinations or presents recommendations to the convened IRB.
• Serves as a voting member of the convened IRB and a designated Expedited Reviewer to review and approve non-exempt minimal risk research using expedited review procedures.
• Provides technical support and guidance on regulatory matters during convened IRB meetings.
• Conducts expedited reviews, documents application-specific findings and generates investigator notifications regarding the outcome of the review.
• Exercises the authority to make not-human subjects research and exempt determinations.
• Conducts evaluations of investigator's response to identify potential issues for IRB reviewers and advise as to whether the requirements for IRB approval have been met.
• Manages the pre-meeting, meeting and post-meeting activities of the convened IRB, including agenda management, and meeting facilitation and documentation.
• Provides guidance to IRB Administrative Assistants, in support of efficiency and effectiveness of IRB operational activities.
• Drafts, edits and prepares correspondence and notification letters using databases.
• Participates in the orientation and training of IRB personnel, including peers.
• Assists with the orientation of new IRB members and actively participates in the training of new nonscientific IRB members.
• Participates in IRB-related quality and educational activities as needed.
Requirements
• Sound judgment
• Analytical skills
• Organizational skills
• Time management skills
• Knowledgeable about the federal and state regulations governing human subject research, and related institutional policies and procedures
• Strong organizational skills
• Effective teamwork skills
• Ability to manage a large volume of submissions, deadlines, and customer expectations
• Ability to seek clarification or alteration of the submission from Mayo researchers
• Ability to make independent determinations or present recommendations to the convened IRB
• Ability to provide technical support and guidance on regulatory matters during convened IRB meetings
• Ability to document application-specific findings and generate investigator notifications
• Ability to conduct evaluations of investigator's response to identify potential issues for IRB reviewers and advise as to whether the requirements for IRB approval have been met.
• Ability to manage the pre-meeting, meeting and post-meeting activities of the convened IRB.
• Ability to draft, edit and prepare correspondence and notification letters using databases.
• Ability to participate in the orientation and training of IRB personnel, including peers.
• Ability to assist with the orientation of new IRB members.
• Ability to actively participate in the training of new nonscientific IRB members.
• Ability to participate in IRB-related quality and educational activities as needed.
Benefits
• Competitive compensation
• Comprehensive benefit plans
• Continuing education and advancement opportunities
• Medical: Multiple plan options.
• Dental: Delta Dental or reimbursement account for flexible coverage.
• Vision: Affordable plan with national network.
• Pre-Tax Savings: HSA and FSAs for eligible expenses.
• Retirement: Competitive retirement package to secure your future.
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Apply To this Job
The IRB Specialist is primarily responsible for the management of a caseload of applications submitted for IRB review and demonstrates sound judgment, as well as analytical, organizational, and time management skills. Serves as a critical link between and is an expert resource for the Mayo research community (principal investigators and other study personnel), the Mayo's Office for Human Subjects Protection, and the Mayo IRB members; is knowledgeable about the federal and state regulations governing human subject research, and related institutional policies and procedures; continuously interprets and applies these requirements to human subject research proposals and ongoing research activities; performs a detailed analysis of all applications submitted for IRB review; manages the disposition of items submitted electronically for IRB review. This includes assessments of completeness, accuracy, and level of review required. Applies strong organizational skills and effective teamwork skills to manage a large volume of submissions, deadlines, and customer expectations; completes critical and comprehensive review of submissions, seeks clarification or alteration of the submission from Mayo researchers, and makes independent determinations or presents recommendations to the convened IRB. Serves as a voting member of the convened IRB and a designated Expedited Reviewer to review and approve non-exempt minimal risk research using expedited review procedures; provides technical support and guidance on regulatory matters during convened IRB meetings; conducts expedited reviews, documents application-specific findings and generates investigator notifications regarding the outcome of the review. Exercises the authority to make not-human subjects research and exempt determinations; responsible for conducting evaluations of investigator's response to identify potential issues for IRB reviewers and advise as to whether the requirements for IRB approval have been met. In partnership with the IRB Chairs, is responsible for managing the pre-meeting, meeting and post-meeting activities of the convened IRB. This includes agenda management, and meeting facilitation and documentation. Provides guidance to IRB Administrative Assistants, in support of efficiency and effectiveness of IRB operational activities and drafts, edits and prepares correspondence and notification letters using databases. Participates in the orientation and training of IRB personnel, including peers. Assists with the orientation of new IRB members and actively participates in the training of new nonscientific IRB members and participate in IRB-related quality and educational activities as needed.
Responsibilities
• Management of a caseload of applications submitted for IRB review.
• Serves as a critical link between and is an expert resource for the Mayo research community, the Mayo's Office for Human Subjects Protection, and the Mayo IRB members.
• Interprets and applies federal and state regulations governing human subject research, and related institutional policies and procedures to human subject research proposals and ongoing research activities.
• Performs a detailed analysis of all applications submitted for IRB review.
• Manages the disposition of items submitted electronically for IRB review, including assessments of completeness, accuracy, and level of review required.
• Completes critical and comprehensive review of submissions, seeks clarification or alteration of the submission from Mayo researchers, and makes independent determinations or presents recommendations to the convened IRB.
• Serves as a voting member of the convened IRB and a designated Expedited Reviewer to review and approve non-exempt minimal risk research using expedited review procedures.
• Provides technical support and guidance on regulatory matters during convened IRB meetings.
• Conducts expedited reviews, documents application-specific findings and generates investigator notifications regarding the outcome of the review.
• Exercises the authority to make not-human subjects research and exempt determinations.
• Conducts evaluations of investigator's response to identify potential issues for IRB reviewers and advise as to whether the requirements for IRB approval have been met.
• Manages the pre-meeting, meeting and post-meeting activities of the convened IRB, including agenda management, and meeting facilitation and documentation.
• Provides guidance to IRB Administrative Assistants, in support of efficiency and effectiveness of IRB operational activities.
• Drafts, edits and prepares correspondence and notification letters using databases.
• Participates in the orientation and training of IRB personnel, including peers.
• Assists with the orientation of new IRB members and actively participates in the training of new nonscientific IRB members.
• Participates in IRB-related quality and educational activities as needed.
Requirements
• Sound judgment
• Analytical skills
• Organizational skills
• Time management skills
• Knowledgeable about the federal and state regulations governing human subject research, and related institutional policies and procedures
• Strong organizational skills
• Effective teamwork skills
• Ability to manage a large volume of submissions, deadlines, and customer expectations
• Ability to seek clarification or alteration of the submission from Mayo researchers
• Ability to make independent determinations or present recommendations to the convened IRB
• Ability to provide technical support and guidance on regulatory matters during convened IRB meetings
• Ability to document application-specific findings and generate investigator notifications
• Ability to conduct evaluations of investigator's response to identify potential issues for IRB reviewers and advise as to whether the requirements for IRB approval have been met.
• Ability to manage the pre-meeting, meeting and post-meeting activities of the convened IRB.
• Ability to draft, edit and prepare correspondence and notification letters using databases.
• Ability to participate in the orientation and training of IRB personnel, including peers.
• Ability to assist with the orientation of new IRB members.
• Ability to actively participate in the training of new nonscientific IRB members.
• Ability to participate in IRB-related quality and educational activities as needed.
Benefits
• Competitive compensation
• Comprehensive benefit plans
• Continuing education and advancement opportunities
• Medical: Multiple plan options.
• Dental: Delta Dental or reimbursement account for flexible coverage.
• Vision: Affordable plan with national network.
• Pre-Tax Savings: HSA and FSAs for eligible expenses.
• Retirement: Competitive retirement package to secure your future.
Apply tot his job
Apply To this Job