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RESEARCH MANAGER- Regulatory Strategy

Company: University of Washington
Location: Seattle
Posted on: November 25, 2022

Job Description:

If you are using a screen reader and experience any difficulty accessing our web pages, please call 206-543-2544 or email UWHires and we will be happy to assist you. jump to content Department: DEPARTMENT OF MEDICINE: GENERAL INTERNAL MEDICINE Job Location: Seattle - Other Posting Date: 11/15/2022 Closing Info: Open Until Filled Salary: Salary and benefits are competitive. Salary is commensurate with qualifications and experience. Shift: First Shift Notes: As a UW employee, you will enjoy generous benefits and work/life programs. For a complete description of our benefits for this position, please visit our website, click here. As a UW employee, you have a unique opportunity to change lives on our campuses, in our state and around the world. UW employees offer their boundless energy, creative problem-solving skills and dedication to build stronger minds and a healthier world.

UW faculty and staff also enjoy outstanding benefits, professional growth opportunities and unique resources in an environment noted for diversity, intellectual excitement, artistic pursuits and natural beauty.

The Division of General Internal Medicine is the largest and most complex division in the Department of Medicine, with an overall budget of nearly $50,000,000, consisting of patient care revenue, sponsored research funds, endowments and gifts, state funds and affiliated hospital funding associated with the academic and clinical programs within the Division. The Division consists of approximately 400 faculty and staff, with three sections across Seattle and in Boise, Idaho. The Division encompasses units located at multiple sites including the University of Washington, Harborview Medical Center, Veterans Administration Puget Sound Health Care Services, Veterans Administration Boise, the Fred Hutchinson Cancer Research Center and other outside institutions.

The Division of General Internal Medicine in the Department of Medicine has an outstanding opportunity for a full-time Research Manager - Regulatory Strategy to join their team.


The Research Manager - Regulatory Strategy will serve as a leader and key team member involved in emerging research projects in the Center for Prehospital Emergency Care. This position will provide technical expertise, scientific planning, and leadership to develop strategic plans and contribute to decision making of complex research plans in the unit. They will also oversee implementation of these plans once approved by responsible regulatory agencies and/or human subject committees.

The Research Manager - Regulatory Strategy will bring dedicated knowledge about the intersection of medical products, clinical research, and regulatory strategy to cooperate in the design of specialized clinical protocols and regulatory plans to advance emergency medicine and medical device research at the University of Washington. In this role, the Assistant Director will plan detailed phases of research and make substantial contributions to multiple projects to improve the feasibility of research designs and strategies.

This position will work closely with team members to evaluate proposed and existing studies, provide ideas, identify problems, and develop new strategies to implement solutions across the research program. In this effort, this position will provide clinical and regulatory research direction to staff and faculty and redirect efforts to achieve objectives, improve quality, and increase research opportunities. The Research Manager - Regulatory Strategy will ensure all research follows relevant institutional policies and requirements and conforms to state and federal regulations

The Research Manager - Regulatory Strategy will work collaboratively with team members and will play a critical role in liaising among research stakeholders and maintaining those relationships to advance goals of the research program.


The Manager will provide leadership and expertise through a set of responsibilities that include:

Advising in Specialized Research Design (40% FTE)

The Research Manager will manage a portfolio of research, advising on approaches and methods to be used in a study and contributing to the design of specific phases of research. This position will use knowledge of specialized research designs and methods, including Exception from Informed Consent research, to advise on human subjects related issues. In this capacity, the Research Manager will:

  • Provide regulatory and clinical advice to center or affiliated faculty and staff to increase the success of the research program
  • Participate in protocol review discussions concerning scientific and procedural aspects of study design
  • Prepare clinical protocols and author clinical sections of regulatory and other documents for investigator-initiated research
  • Prepare and oversee regulatory submissions ensuring compliance with the Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA).
  • Develop and advise on materials for dissemination to sites for multi-center research
  • Contribute to the preparation and/or review of data listings, summary tables, study results, manuscripts, and scientific presentations
  • Oversee and advise on FDA and IRB-related inspections or audits
  • Provide direction to resolve problems affecting research program
  • Provide mentorship and training in specialized research topics

    Supervision and Development of Staff (25% FTE)

  • Oversee and supervise project staff as required. This includes actively collaborating with and supervising project staff in conduct of clinical studies under exception from informed consent for emergency research.
  • Develop, implement, and monitor as required center-specific standard operating procedures (SOP)s for qualification of a clinical study under exception from informed consent for emergency research.
  • Develop, implement, and monitor as required center-specific standard operating procedures (SOP)s for conduct of clinical studies under exception from informed consent for emergency research.

    Communications (25% FTE)

    The Research Manager will implement and maintain sustained collaborative relationships with internal and external team members, research stakeholders, and agencies. This may include technical groups, project management, collaborators at external sites, clinic liaisons, funding, and compliance agencies. In this capacity, the Research Manager will:

  • Collaborate with team members, internal and external to the UW
  • Oversee communications with outside agencies and stakeholders as needed to resolve key regulatory issues
  • Manage and represent study teams during problems in research, develop and manage corrective action plans, and direct new policies to evolve research conduct
  • Respond to other nuanced issues and requirements that require verbal and written regulatory justifications, discretion, and diplomacy
  • Communicate changes and updates to team members
  • Initiate and/or actively participate in dissemination of center's experience with exception from informed consent for emergency research in collaboration with the center director.

    Leadership and Planning (10% FTE)

    The Research Manager will manage, oversee, and lead the short-term and long-term planning of regulatory initiatives that are designed to reach research program goals, improve best practices, and create efficiencies. This position exercises a high degree of judgement and will direct key decisions for the research program. In this capacity, the Research Manager will:

  • (Co) lead development of new research grants and/or contracts that fit with the Center's program portfolio
  • Review incoming projects for program fit, strategic direction, and regulatory practices
  • Collaborate closely with other research leaders and stakeholders in developing and communicating strategies to increase organizational effectiveness and to meet internal and external requirements
  • Develop and oversee implementation of community consultation and public disclosure plans to facilitate participation of internal and external study sites in multi-center research
  • Develop and oversee implementation of regulatory policies and procedures to ensure quality and compliance with good clinical practice.
  • Provide direction for decisions on project vendors, to optimize relationships and compliance
  • Conduct assessments throughout conduct of research to mitigate risks and improve research processes
  • Participate in or lead as required meetings with sponsors, committees, and other oversight bodies, as needed
  • Actively contribute to obtaining research grants through grant writing and editing, and planning for new submissions and renewals
  • Lead other professional administrative and/or programmatic functions related to regulatory issues in emergency care as required.


  • Bachelor's degree in science, or related field or an equivalent combination of education and experience
  • 5 years of progressive scientific, clinical, and/or regulatory experience or equivalent education

    Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.


  • Experience with development of justification for conduct of a study under exception from informed consent for emergency research
  • Working knowledge of institutional review process for human subjects research
  • Knowledge of device safety regulations and processes and clinical trial oversight
  • Experience working in emergency medicine research
  • High level of tact, discretion, and the ability to independently devise new approaches to problems encountered
  • Working knowledge of biostatistics, GCP, and regulatory requirements for clinical studies.
  • Excellent written communication skills and the ability to draft complex correspondence, and policies and procedures
  • Strong interpersonal, communications and collaboration skills


  • Master's Degree in Health Sciences, Public Health, Legal Studies, or related field
  • Demonstrated ability to work well independently and in teams
  • Experience in grant writing
  • Experiencing in an advising or program leadership role
  • Previous experience mentoring and supervising research staff
  • Knowledge of the device discovery process
  • Experience and advanced skill using Microsoft Office (including PowerPoint, SharePoint, Word, Excel, Access)
  • Experience working in a dynamic environment engaging with different internal and external stakeholders

    Application Process:

    The application process for UW positions may include completion of a variety of online assessments to obtain additional information that will be used in the evaluation process. These assessments may include Work Authorization, Cover Letter and/or others. Any assessments that you need to complete will appear on your screen as soon as you select "Apply to this position". Once you begin an assessment, it must be completed at that time; if you do not complete the assessment, you will be prompted to do so the next time you access your "My Jobs" page. If you select to take it later, it will appear on your "My Jobs" page to take when you are ready. Please note that your application will not be reviewed, and you will not be considered for this position until all required assessments have been completed.
    Applicants considered for this position will be required to disclose if they are the subject of any substantiated findings or current investigations related to sexual misconduct at their current employment and past employment. Disclosure is required under Washington state law .

    Committed to attracting and retaining a diverse staff, the University of Washington will honor your experiences, perspectives and unique identity. Together, our community strives to create and maintain working and learning environments that are inclusive, equitable and welcoming.To request disability accommodation in the application process, contact the Disability Services Office at 206-543-6450 or .COVID-19 VACCINATION REQUIREMENTEmployees of the University of Washington are required to be fully vaccinated against COVID-19 unless a medical or religious exemption is approved. Being fully vaccinated means that an individual is at least two weeks past their final dose of an authorized COVID-19 vaccine regimen. As a condition of employment, newly hired employees will be required to provide proof of their COVID-19 vaccination. View the Final candidate guide to COVID-19 vaccination requirement webpage for information about the medical or religious exemption process for final candidates.

Keywords: University of Washington, Seattle , RESEARCH MANAGER- Regulatory Strategy, Executive , Seattle, Washington

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