1+ months

POST APPROVAL MONITOR

University of Washington
Seattle, WA 98104

POST APPROVAL MONITOR

Req #: 174303
Department: HUMAN SUBJECTS DIVISION
Job Location: Other Location
Job Location Detail: UW Tower 
Posting Date: 11/22/2019 
Closing Info: Open Until Filled 
Salary: Salary is commensurate with experience and education. 
Shift: First Shift 
Notes: As a UW employee, you will enjoy generous benefits and work/life programs.  For detailed information on Benefits for this position, 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. All of which has allowed the UW to be nationally recognized as a Great College to Work For for six consecutive years. 

The University of Washingtons Office Human Subjects Division (HSD) within the Office of Research, has an outstanding opportunity for a full time Post Approval Monitor based at UW Tower.

The Post Approval Monitor (PAM) is a member of the Human Subjects Division (HSD) Regulatory Affairs team and reports to the Assistant Director of Regulatory Affairs.  The team is generally responsible for the assessment of compliance and promotion of best practices regarding UW human subjects research.  The primary PAM responsibilities are to: (1) identify and select appropriate studies for post-approval monitoring; and (2) conduct post-approval monitoring activities to ensure that studies are proceeding according to protocols established in the planning, review and approval phases of study development, and to assist researchers in meeting that goal.

UW research is remarkably diverse. About 7000 active studies are distributed across almost every department and academic unit, including the Bothell and Tacoma campus. The research may occur anywhere in the world; a significant percentage of UW research occurs outside of the U.S.  Studies may focus on biomedical issues, or on social/behavioral/educational issues. Risk levels range from no or minimal risk to very risky studies of an investigational drug being used for the first time in humans. The lead researcher may be an experienced faculty member, an inexperienced graduate or undergraduate student, or a UW staff member. Though post-approval monitoring may occur for any study, the PAM program generally prioritizes clinical trials and other research involving significant risk, vulnerable populations, or specific compliance challenges. Diversity of regulations. The PAM must thoroughly understand a variety of complex regulatory and ethical issues. This includes at least four different sets of federal regulations, in addition to applicable state law and HSD policies. The regulations do not generally consist of a sharp, clear-cut set of specific rules; instead, the assessment of regulatory compliance requires nuanced interpretation and resolution of frequent ambiguity.

The PAM needs to work closely and collaboratively with multiple individuals, programs, and offices. This includes other HSD staff (e.g., the Compliance Administrators, Team Operations Leads, training staff, and HSD management). This may also occasionally include other UW compliance assessment and service programs.

RESPONSIBILITIES:

Conduct post-approval monitoring visits
Select research studies to monitor based on current priorities and HSD/IRB requests; develop the monitoring plan; perform the visit. The visit may be for-cause (i.e., at the request of an IRB or HSD management) or not-for-cause; it may be focused or comprehensive. May involve obtaining and auditing study documentation. Usually requires going to local research sites to perform on-site auditing of records and (possibly) on-site observation of study procedures.

Reporting and communication
Communicate PAM observations to researchers, HSD Compliance Administrators, the IRBs, and HSD management, using detailed written reports. Develop and provide relevant metrics about PAM reviews and outcomes.

Researcher education, consultation and guidance
Provide education, consultation and problem-solving to researchers about regulatory, ethical, and methodological issues observed during post-approval monitoring visits using written reports, phone conversations, email, and in-person meetings.  May also involve conducting general or targeted training on compliance and best practices for researchers, or working with HSD training staff to develop such training.

Quality Assurance
Perform quality assurance reviews of post-approval monitoring reports prepared by other PAMs pre- and post-visit to ensure accuracy with the IRB approved procedures and Post Approval Monitoring program requirements.

Organizational effectiveness
Propose pro-active, as well as reactive strategies and methods to address needs and possible areas of improvement, based on post-approval monitoring observations and experience.  Participate in relevant HSD organizational effectiveness initiatives.  May include development of policies, procedures, guidance, and forms.  For example, post-approval monitoring observations might indicate that a written HSD procedure is consistently misinterpreted by researchers, leading the PAM to suggest revisions.

Cross-team support
Provide cross-team (Regulatory Affairs) support for other Regulatory Affairs team functions as needed.Examples include:coverage while someone is out of the office; ClinicalTrials.gov registrations; receiving subject inquiries.

Other duties as assigned by the Assistant Director of Regulatory Affairs or the HSD Director.

REQUIREMENTS:

  • Bachelors degree in a field that requires scholarly research.  An advanced degree is preferred.
  • A minimum of 5 years of progressively responsible experience in human subjects research administration, or other field requiring familiarity with research methodologies. A detailed knowledge and understanding of the implementation of a complex regulatory system is required. An equivalent combination of education and/or experience may substitute for the stated requirements.
  • Demonstrated outstanding interpersonal and communications skills (both written and spoken) are required, particularly the ability to write and speak in a concise, accurate, and intelligible manner.
  • Demonstrated ability to work both independently with minimal supervision and as part of a team with academic researchers and others.
  • Computer proficiency is required, including MS Word, Excel, internet browsers, and email. Almost all duties require extensive reading.  Most information is either in an electronic web-based system or scanned files, which requires individuals to be comfortable reading on a screen rather than paper and to easily switch back and forth between screens to obtain and synthesize information.
  • Demonstrated experience at managing, tracking, organizing, prioritizing and documenting large volumes of complex tasks and information (in paper and/or electronic form).
  • Demonstrated experience at working collaboratively with others to find creative solutions to problems.
  • Demonstrated experience involving outstanding attention detail.

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

    DESIRED:

  • A Masters Degree in a field that requires scholarly research
  • Experience in higher education is preferred; familiarity with a complex large research university is preferred, and/or experience in a higher education medical center
  • Experience with performing clinical research site monitoring/audits
    Professional IRB Certification (CIP)

    CONDITIONS OF EMPLOYMENT:

    HSD occupies two floors in the UW Tower, with a layout that consists mostly of cubicles. Some weekend and evening work may be required (at home or in the office), due to work volume or researcher scheduling conflicts. Meetings and post-approval monitoring will occur all across campus and at some locations away from the main campus (e.g., Harborview; South Lake Union, Seattle Cancer Care Alliance) which may require frequent and extensive walking, bus or shuttle rides, or (less frequently) driving.

    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.
  • 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.

    The University of Washington is a leader in environmental stewardship & sustainability, and committed to becoming climate neutral.

    The University of Washington is an equal opportunity, affirmative action employer. To request disability accommodation in the application process, contact the Disability Services Office at 206-543-6450 / 206-543-6452 (tty) or dso@uw.edu.


    Categories

    Posted: 2019-12-05 Expires: 2020-02-02

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    POST APPROVAL MONITOR

    University of Washington
    Seattle, WA 98104
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