About this role
Position Overview
Under the supervision of the Director of Research Operations and Compliance, the Manager of Research Ethics and Compliance supports the review, documentation, and coordination of research and evaluation activities for the 988 Suicide & Crisis Lifeline and other Vibrant research and evaluation activities as applicable. This role conducts initial ethics and compliance screening for research-like activities, including activities that may require IRB review, PRA/OMB review, sponsor/funder clearance, organizational review, or other oversight. The Manager reviews study protocols, data collection tools, research products, and related materials for alignment with ethical standards, participant protections, and research governance requirements. This position prepares documentation and recommendations for Research and Evaluation leadership review, supports appropriate distinctions among quality improvement, evaluation, and research activities, and offers opportunities to contribute to research products such as manuscripts, white papers, reports, and other dissemination materials.
Duties/Responsibilities
- Conduct initial IRB and PRA/OMB screening for research-like activities and prepare documentation, summaries, and recommendations for Research and Evaluation leadership review.
- Review study protocols, evaluation plans, external research request materials, data collection tools, recruitment materials, consent language, and related documents for alignment with ethical standards, participant protections, data access considerations, and applicability to a crisis line context.
- Support appropriate distinctions among quality improvement, evaluation, and research activities and route activities for appropriate review based on established processes.
- Review research and evaluation products for ethical considerations prior to dissemination, sponsor/funder clearance, or organizational review.
- Contribute to the development of research and evaluation products, including manuscripts, white papers, reports, and other dissemination materials as appropriate.
- Support preparation of project review templates, external research request documentation, determination letter drafts, decision logs, and any other needed documentation materials related to research ethics and compliance review.
- Coordinate with the Director of Research Operations and Compliance and, as appropriate, the Lead Research Scientist or Research Scientists to identify ethics, regulatory, data collection/access, participant protection, external research request, or dissemination issues that require escalation.
- Apply established research governance standards, review criteria, documentation expectations, and escalation pathways consistently across assigned activities.
- Provide guidance to internal partners on research ethics review procedures, documentation requirements, and participant protection considerations.
- Support process improvements related to ethics screening, protocol review, documentation quality, and research governance workflows.
Decision Making
- Identifies ethics, compliance, participant protection, data collection, data access, and dissemination issues that may affect assigned research and evaluation activities or external research requests.
- Determines whether submitted materials are complete enough for ethics and compliance screening based on established intake and documentation requirements.
- Analyzes protocols, tools, external research request materials, project descriptions, and dissemination materials to identify potential risks and recommend appropriate review pathways.
- Prepares recommendations regarding IRB review, PRA/OMB review, organizational review, sponsor/funder clearance, or other oversight for Research and Evaluation leadership consideration.
- Recommends revisions to protocols, data collection tools, consent language, external research request materials, research products, or documentation to improve alignment with ethical standards and participant protections.
- Escalates complex, high-risk, unclear, or precedent-setting ethics, regulatory, data access, or participant protection issues to the Director of Research Operations and Compliance.
- Implements approved review procedures, documentation practices, and process improvements for assigned work.
Scope of Responsibility/Accountability
- Responsible for conducting ethics and compliance screening for assigned research-like activities and preparing recommendations for Research and Evaluation leadership review.
- Accountable for the quality, accuracy, and completeness of assigned ethics review documentation, summaries, decision logs, and recommendation materials.
- Responsible for reviewing assigned materials for alignment with ethical standards, participant protections, data access considerations, and applicability to a crisis line context.
- Supports consistent implementation of internal review processes related to IRB/PRA screening, organizational review, sponsor/funder clearance, data access review, and dissemination review.
- Supports documentation needed to demonstrate Research and Evaluation compliance with Vibrant’s Federalwide Assurance, federal grant requirements, 988 Lifeline Network Agreement research and evaluation requirements, and organizational standards.
- Responsible for identifying and escalating ethics, compliance, participant protection, data access, or documentation issues that require Director or AVP review.
- Performance is reviewed by the Director of Research Operations and Compliance and other leaders as applicable.
Managing/Directing Work
- Manages assigned ethics and compliance review tasks with minimal day-to-day supervision.
- Organizes review timelines, documentation needs, follow-up items, and assigned deliverables to support timely completion of research governance processes.
- Coordinates with internal partners, external researchers, and Research and Evaluation scientific staff to obtain missing materials, clarify project details, and support completion of required review documentation.
- Provides constructive feedback to internal partners and external researchers on project plans, data collection tools, consent materials, research products, and external research request materials based on established review standards.
- Participates in planning, implementing, and evaluating improvements to ethics screening, documentation, review