Jennifer Kogut Email & Phone Number

Seattle, Washington

Leadership:-Oversee the effective operations of the research compliance programs (IRB & IACUC) and collaboratively lead departmental initiatives and manage Institutional Review Office staff.-Oversee the IRO quality management program, including policy and procedure management and post-approval monitoring. Identify issues of consistency and inefficiency in departmental documentation.-Resolve data management and Huron module issues.-Help resolve pain points and submission issues.-Model positive, direct, and calm communication, conflict resolution and customer service for all constituents.Regulatory Expertise:-Serve research teams and IRO staff by assisting with application and review process as well as regulatory compliance decision-making. -Independently assess engagement of Fred Hutch in human subjects research and whether projects meet definition of research. Education & Training:-Collaborate with research teams and administrative departments across Fred Hutch as well as the other Cancer Consortium institutions (University of Washington and Seattle Children’s Hospital).-Manage education and training initiatives for IRB.Support the IRB/IACUC Committees:-Collaborate with Chairs, the Office of General Counsel and the Institutional Official on policy and process changes as well as recurring concerns.-Prepare for and attend all committee meetings; actively support regulatory determinations and discussions; oversee continuing education for members; and support on boarding of new committee members.-Support consistent, timely, and thorough assessment of submission materials by IRO staff.-Substantive edits of meeting minutes.Key accomplishments:* Successfully transitioned the office, and all committee meetings and designated reviews, from paper-based to remote at the onset of the Covid pandemic* Instrumental in design and implementation of Huron IRB module, adapted to unique context of our role as the “Cancer Consortium IRB”

Seattle, Washington

Managed day-to-day operations of the IRB staff to ensure that the IRB staff provides the best possible support to IRB Committees and excellent service to investigators and research staff at Fred Hutch and the Cancer Consortium institutions. Supported the IRB Chairs and IRB members individually, and in weekly IRB meetings, with regulatory expertise related to OHRP, NIH, and FDA regulations as well as local policies and processes. Supported researchers and study teams with their complex submissions, regulatory compliance, and non-compliance or unanticipated problem submissions.Critical results included:* Consistent, timely, thorough preparation of IRB materials and documentation* Well-developed, high-trust, high-performance work team* Quality customer service and consultancy to all constituents* Collaborative management of the Institutional Review Office with the Assistant Director* Helped facilitate AAHRPP reaccreditation for the Fred Hutch Human Subjects Research Protection ProgramKey accomplishments:* Trained and resourced additional Expedited Reviewers: With the Assistant Director, trained an additional group of Expedited reviewers to relieve workload of IRB Chairs; continue supporting the new reviewers with process, procedure, and regulatory questions on an on-going basis.* Supported task shifting and additional coverage plans for Analyst team: Successfully addressed equity and workload concerns by developing detailed coverage plans for outages. Worked with different personalities to help team adopt a more collaborative team approach. * Adapted to revised 2018 Common Rule (OHRP) regulations: Collaboratively updated, trained for, and implemented numerous policy updates addressing the revised regulations.

Seattle, Wa

Performed substantive review of human subject research protocols and consent forms to support compliance with relevant regulations and published guidance, including FDA and OHRP. In particular, considered consent forms and consent process in overall context of the research and according to regulatory criteria. Played a key role in identifying potential issues for the daily Institutional Review Board (IRB) meetings. Queried researchers to gather missing information or to suggest revisions to help bring the research into alignment with regulatory requirements. Presented rationale to the convened Board for consideration and use in the Board determinations. Supported Expedited Reviewers in assessing ethical and regulatory considerations of minimal risk research as a whole and the consent process in particular. Provided input into revisions to IRB guidelines, procedures, consent form language, policies, and forms. Researched federal laws and guidance relating to human subjects research and consent forms and the consent process. Supported institutional account managers in addressing the unique needs of institution-based research, including PI-generated projects. Supported regulatory attorneys in assessing regulatory criteria and company policy updates. Fielded questions from external researchers and staff across the company. Trained and mentored consent form editors. Played a key role in identifying gaps and issues in processes, and supported the quality and success of team and interdepartmental continuous improvement projects. Key accomplishments:* Common Rule Revisions 2018: Key role in company efforts to draft policies and update forms related to consent updates * Trained IRB members on review of phone screener documents.* Collaboration on a flow chart resource to address FDA regulatory requirements related to washout/fasting before consent* Simplified Assent Toolkit: Collaborated to draft resources for clear, understandable language

Seattle, Wa

Successfully provided tactical direction and leadership to a team of 11 Editors, who reviewed protocols and consent form documents and performed consent-related regulatory analysis for the Institutional Review Board (IRB) members.Developed and managed staff with compassion and common sense throughout continuous process improvement and on-going corporate change initiatives. Represented company expectations with clarity and transparency to foster staff buy-in. Recognized employees' unique strengths to provide additional opportunities and maintain engagement. Successfully addressed operational and performance barriers to ensuring high accuracy, adherence to daily deadlines, and excellent cross-departmental customer service. Completed a high volume of project work involving regulatory analysis and cross-team procedure changes.Key Accomplishments:* Managed a substantive overhaul of editing team checklists and templates to ensure regulatory compliance with FDA, OHRP, ICH, TCPS 2 and local/state laws and published guidance. Supported efficiency and clarity of process. Developed appropriate training that enabled a seamless and rapid adoption of the new documents.* Supported company initiative to welcome institution-based research, with its own unique considerations and requirements.* Oversaw team's successful transition to the company-wide Paperless Initiative, including new software and SOPs.* Fostered collaboration through the development of a team lead structure and mentorship program for new editors.

Seattle, Wa

Actively promoted protection of subjects in U.S. and Canadian clinical trials by drafting and editing consent-related documents undergoing ethical, scientific, and regulatory review by a commercial Institutional Review Board (IRB). Edited documents for accuracy, thoroughness, and compliance with federal and state/provincial regulations. Adapted technical and medical information for general audience readability and ensured compliance with extremely complex checklists and guidance documents. Communicated successfully with account managers, regulatory advisors, managers and Board members to resolve consent form questions and concerns. Presented and discussed regulatory rationale for edits at IRB meetings with medical and non-scientific Board members. Key Accomplishments:* Recognized for expertise and a leadership role on the team within less than 8 months of hire, in a complex position that normally requires a full year for mere basic competence.* Edited team checklists for greater clarity and compliance.* Valued for providing tactful and careful analysis and editing for some of the team's most sensitive customer service projects (client templates).

Seattle, Wa

Wasser Studios (now defunct) developed and deployed written, graphic, and multimedia content for both online and print marketing and technical communications. Reviewed publications in all stages, from rough drafts to final print proofs or on-line launch. Checked documents for adherence to client style guides. Assessed and marked corrections in language usage, consistency, clarity, grammar, spelling, punctuation, and formatting. Submitted queries to writers, including suggested revisions. Checked that localized documents accurately matched English source documents (in both content and formatting) in up to 32 languages, including European, Asian, and Middle Eastern.Primary clients included Hewlett-Packard and Siemens. Document types included online help files, user guides, warranty and support, quick start guides, customer self-repair and part replacement instructions, troubleshooting and maintenance, and medical device manuals.

Seattle, Wa

Advised prospective applicants and students about academic programs, admissions, and transfer policies and procedures. Performed detailed analysis of applications to determine admissibility of prospective students. Evaluated and processed appropriate transfer equivalency credits for students transferring from other colleges nationwide and internationally. Represented the university at transfer student fairs and community colleges. Recruited to proofread new Admissions website and print materials before launch.

Seattle, Wa

Centerpoint Institute provides counseling and coursework to guide people in creating more meaningful and passionate lives and careers.Managed and trained front desk staff and volunteers. Wrote, copyedited, and designed instructional materials and marketing items (including catalogs, syllabi, brochures, and flyers). Scheduled appointments and handled client intake. Conducted new client group orientations and career forums.

Seattle, Wa

The Northwest School is an independent middle and high school graduating students with historical, scientific, artistic, and global perspective, enabling them to think and act with integrity.Coordinated processing of 3,000 student evaluations five times per year for over 400 students. Assisted with registrar functions and transcript preparation. Compiled yearly school directory and monthly addenda. Counseled high school students about graduation requirements and college application process. Proofread all school-wide publications prior to distribution (including course catalogs, websites, articles, newsletters, marketing materials, directories, faculty biographies, event flyers and programs, and annual budget reports).

B.A., French - Linguistics Emphasis

Activities and Societies: College Honors program, Phi Beta Kappa Honor Society Graduated magna cum laude with major in French, linguistics.

Technical & Professional Editing