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    research operations manager - Seattle, United States - University of Washington

    University of Washington
    University of Washington Seattle, United States

    3 weeks ago

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    Description

    RESEARCH OPERATIONS MANAGER

    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 University of Washington's Department of Emergency Medicine within the School of Medicine has a workforce of over 170, with 80+ faculty members who are known for their outstanding research, teaching and patient care. The Department conducts its activities at the Harborview Medical Center (HMC), UW Medical Center-Montlake, UW Medical Center- Northwest, with research sites located at multiple sites across Seattle. This position requires in-person presence.

    The Research Operations Manager will serve as a leader within our clinical trials unit and will work under the general direction of the Associate Director of Research Operations and the Assistant Director of Department Operations. The Research Operations Manager will provide research support for the department and will lead the clinical and health services research unit by serving as the supervisor to clinical research staff. The appointee will coordinate and perform research in support of clinical and health services research across the department. The department's research projects cover a wide range of pathways. Personnel within this unit work as part of a collaborative team of Principal Investigators (PIs) and research staff. This position requires excellent project implementation and management skills, knowledge of in human subject research activities, and operational analysis skills for data collection and management.

    The appointee must be able to pivot with project changes and shifts in work activity based on the needs of the department. This position will also require extensive interaction with Emergency Department staff, including physicians and nurses.

    DUTIES AND RESPONSIBILITIES
    Management (15%)
  • Lead the clinical research unit of the Department of Emergency Medicine.
  • Supervise clinical research operations and perform administrative tasks. One of the primary functions of this position is to arrange 24/7 RA and RC coverage and maintain staff schedules to ensure projects are meeting milestones for completion.
  • Troubleshoot issues and bring proposed solutions to Associate Director for input when needed.

    Project implementation/management activities (35%)
  • Guide project direction and create project timelines and deliverables for PI; track and manage timelines.
  • Collaborate with department grant manager to ensure spending is within budget. Processes reimbursements for expenses and track project spending and subject compensation.
  • Track grant timelines and ensure that attention and resources are allocated appropriately for study milestones to be met on time.
  • Collaborate with and advise other research team members on project direction and priorities.
  • Coordinate and attend research project team meetings; develop and draft agendas and track action items.
  • Attend weekly research team meetings and regular meetings with local stakeholders; including persons from UW/HMC and Study and/or network sponsors.
  • Coordinate and contribute to manuscript and abstract preparation and submission.
  • Function as Lead Coordinator and supervise junior research team members.
  • Assist with developing and coordinating detailed study protocol and research assessment instruments with study sponsors.

    Human subject research activities (15%)
  • Recruit, screen, and consent research participants.
  • Carry out randomization procedures and ensure the adherence to study protocols for study participants.
  • Facilitate timely enrollment of study participants and explanation of research procedures to participants and clinical team.
  • Serve as primary liaison with clinical team, pharmacy and lab staff.
  • Ensure informed consent forms from participants and participant family members have been obtained.
  • Ensure Federal and State Regulatory compliance including HIPAA.
  • Actively contribute writing IRB applications/modifications for complex research protocols.
  • Serve as primary point of contact for research participant recruitment, scheduling and questions about studies.

    Data Collection/Management (15%)
  • Use and coordinate research management systems (such as RedCap) and other study databases to track study workflow, participation and engagement, and data quality; generate monthly reports.
  • Work with the team to manage multiple data collection efforts which may include collaborating agencies or institutions. Including the development, testing and dissemination of project materials, such as participant surveys, informed consents, recruitment letters, and pathologist continuing medical education materials.
  • Monitor and manage collected data; perform periodic quality checks to ensure the integrity of the data collected in collaboration with local research staff, other site staff as well as the study's analytic core staff.
  • Facilitate sponsor monitoring permissions and facilitate any SIV or other sponsor visits.
  • Contribute to data cleaning and assist statisticians with analysis. Confirm accuracy of participant data analyses and proactively identify potential programing errors.
  • Oversee the data collection process and assist the Research Study Assistants as needed.
  • Monitor and manage collected data; perform periodic quality checks to ensure the integrity of the data collected.
  • Assist with formatting and submission of manuscripts to scientific journals.

    Protocol Management and Regulatory Compliance - 20%
  • Design, create, complete, and revise research instruments (case and control consent forms) as necessary to ensure quality data that correlates with research objectives.
  • Understand and ensure compliance with all IRB Protocols within the Department.
  • Support all research faculty and trainees in the Department with IRB creation, submissions and compliance. This includes annual renewals, new protocols, modifications, and study closeout.

    MINIMUM REQUIREMENTS
  • Bachelor's Degree in health or science-related field and three years of related work experience.
  • Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.

    ADDITIONAL REQUIREMENTS
  • Advanced skills in MS Word, Excel and PowerPoint.
  • Strong attention to detail and ability to multitask.
  • Ability to organize and adjust to rapidly changing priorities and new projects; ability to collaborate and work effectively on multiple projects with limited supervision.
  • Excellent problem solving, communication skills, and the ability to work with a multidisciplinary team.

    DESIRED QUALIFICATIONS
  • Previous professional experience working in large health-related research studies (preferably multi-site) with multiple PIs.
  • Basic lab skills in human specimen processing including centrifuge and aliquot, etc.
  • Lead Research Coordinator responsibility experience.
  • Recent experience working in an emergency department and intensive care setting preferred.
  • Experience collaborating with industry and network sponsored research.
  • Excellent writing and communication skills, particularly in the context of collaborating with and coordinating a wide variety of stakeholders.
  • Working knowledge of health care systems, medical record databases, public health, and relevant agencies.
  • Excellent writing and communication skills, particularly in the context of collaborating with and coordinating a wide variety of stakeholders.

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