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 purpose of this position is to provide research administrative management and direction for clinical research, to include clinical trials, on the UWMC-Montlake campus. The Division of Cardiothoracic Surgery historically has had a robust clinical research program, primarily, but not solely, in clinical trials (including many device trials). While this position’s responsibilities are not exclusive to Cardiothoracic Surgery, the foreseeable majority of administrative management will be for this Division and the Division of Vascular Surgery and research duties will be specific to the UWMC-Montlake campus.
The Research Manager will be responsible for providing leadership to the entire clinical research endeavor involving human subjects on the UWMC-Montlake campus, including strategic planning and project management for the conduct of trials, expert participation in negotiating clinical research contracts and execution of those contracts with finance operations and the opening, conduction and closing of research projects. In addition, the Research Manager will consult on service strategy and will assist in planning, developing and implementing efforts that support and promote clinical research studies throughout the department.
This individual will hire, supervise and train research coordinators and other junior staff to conduct clinical research, and will have responsibility to ensure regulatory guidelines are known, understood and followed. Such guidelines and regulations include Internal Review Board (IRB) guidelines, Food and Drug Administration (FDA) guidelines and other regulatory bodies. This individual is the direct contact for such governing bodies as the FDA.
This individual must have substantial experience and expertise in the conduct and administration of clinical research and must be an inherently ethical individual who follows protocols, regulatory guidelines and advocates for research participants. The Research Manager will report to the Administrator for Cardiothoracic and Transplant Surgery, with highly matrixed relationships to the PIs on various clinical trials, who will provide input and direction with respect to conduction of clinical research. The major responsibilities of this position are:
Oversight, Management and Conduct of Research that involves Human Subjects (UWMC-Montlake Campus) = 50%
Administrative direction, planning, oversight and compliance management of clinical research program = 30%
Oversight, hiring, training and management of research personnel working on the clinical research. = 20%
Position Complexities: Research Managers at this level have increasingly complex roles and responsibilities. The nature of their work requires that this individual have a high level of independence and know how to be self-motivated and able to take initiative. This individual must be inherently ethical, willing and capable of abiding by the multitude of compliance regulations associated with conducting research with human subjects. The individual in this position is generally the first person a patient interacts with when contemplating becoming part of the research study. Professional, patient-centered interactions with potential and current participants is very important to the success of a study. Importantly, the individual in this role is an advocate for the patient and works diligently to ensure the safety of the patients through the responsible conduct of the research.
The Research Manager, in particular, must be an articulate role model for newer research coordinators. They must have the skill, maturity and certified ability to manage research projects as well as train and monitor more junior staff. Inherent in their skills and abilities will be instilling confidence in the PIs, sponsors as well as the administrative partners they work with.
Position Dimensions and Impact to the University: Clinical research is an important aspect of the University’s research mission. It puts basic research into action and has direct impact upon patients’ lives. Some of the ground-breaking clinical research in cardiothoracic and vascular surgery has been conducted at the University of Washington. Device trials are a common clinical trial that is performed, such as TransMedics Inc. “heart in a box” and Physician-Modified Endografts (PMEG) in thoracic-abdominal aortic aneurysm patients. Because of the large patient population that comes to UW for cardiothoracic and vascular care, UW Medicine has a robust clinical trials program. Finally, clinical research, because of its direct impact upon patients, must be carefully and rigorously conducted. It must always keep the best-interests of the patient in mind, while advancing science. Clinical Research has a profound effect upon the health of the population that UW Medicine serves. Its importance to the dimensions and impact of University cannot be underestimated.
Position Responsibilities Oversight, Management and Conduct of Research that involves Human Subjects (UWMC-Montlake Campus) = 50% Conducting research that involves human subjects; i.e., personally, or in an oversight/supervisory capacity. Activities include, screening, recruiting, consenting, interviewing and performing steps in research protocol on human subjects for assigned research projects.
Establish guidelines for identifying subject populations; develop forms, questionnaires, and clinic procedures for collecting and summarizing observations and data.
Screen, recruit, consent, enroll and track subjects over time according to requirements noted in the research protocol and in compliance with regulatory and institutional requirements for research studies.
Complete selection, preparation and/or shipment of specimens (blood and tissue) for laboratory analysis according to federal regulations.
Serve as liaison between the project team, industry and other stakeholders, including UWMC-Montlake staff and health care providers. Understand who relevant stakeholders are and keep stakeholders appropriately apprised of study progress as needed.
Accurately extract technical, medical and/or behavioral information from institution or clinical records and enter into appropriate data entry programs (either in paper or electronic format).
Complete data accuracy checks/quality control activities.
Answer patient questions and deal with patient concerns in a timely, empathetic and accurate manner.
Ensure all adverse indications are promptly reported and appropriately dealt with.
Carefully monitor study patient follow-up and assure they are cared for according to standard operating procedures and research protocols; take appropriate action to correct problems or deviations that may arise.
Complete reporting of patient status and/or results of research exams and laboratory tests to PI and/or sponsor when appropriate.
Oversee research budgets, alert Division Administrator and PI to any budget problems or concerns that occur; work with Division Administrator and appropriate University bodies to rectify budget problems.
Complete all documentation to sponsors and others associated with finishing a research project in a timely and thorough manner; finalize all patient communication.
Ensure required reports are filed with all appropriate bodies, including regulatory agencies and sponsors.
Administrative direction, planning, oversight and compliance management of clinical research program = 30% Administrative Duties
Develop strategies and processes to create successful clinical research program;
Oversee IRB preparation and submission, so that applications are thorough, accurate and completed in a timely fashion; work in conjunction with other department IRB expertise to ensure compliance
Review and provide expertise on clinical research pricing negotiations;
Review and develop appropriate resources for projects, including staffing over project span;
Develop strategies and drive processes to meet the milestones of complex clinical studies.
Develop and employ tracking tools to ensure timely completion of tasks/milestones.
Establish well organized, systematic, thorough research files (paper and electronic); assure these files are strictly maintained.
Provide timely and thorough reports of adverse events to the PI, the FDA and/or sponsor when appropriate
Advocate for resources to maintain high quality, compliant clinical trials;
Fiscal Duties – Oversee or undertake duties:
Accurate and timely invoicing of sponsor as necessary.
Monitor project budgets; provide accurate budget information to PI and others as needed.
Work with PI and Division Administrator and oversee more junior staff to use budgeted resources responsibly to achieve planned results.
Oversee inventory of project supplies;
Maintain expert knowledge of rules and regulations within the University’s governing bodies, IRB office, Grant & Contracting Accounting (GCA) office as well as outside agencies, including the FDA and other sponsors.
Implement processes and tracking tools to ensure compliance with applicable rules, regulations and protocols;
Ensure education around compliance to all involved, including updating internal staff, administration and other involved parties;
Maintain absolute integrity of study protocols and ensure advocacy/patient safety.
Oversight, hiring, training and management of research personnel working on the clinical research. = 20%
Oversee position creation and hiring activities of appropriate individuals to conduct research involving human subjects;
Train more junior staff in conduct of clinical research; ensure they understand and have the tools to carry out the research endeavors;
Provide oversight and support to employees to ensure clinical research is conducted in timely and compliant manner;
Ensure general training and development as well as specific clinical trial training is complete; monitoring junior RC’s to ensure they understand all aspects of their duties within the trials;
Manage performance of assigned staff.
Work to create an environment that promotes excellence and growth of junior staff.
Job Qualifications Education: Bachelor’s degree in public health, life sciences, psychology or similar or BSN Type and Years of Experience: 4-5 years’ experience in research study coordination with human subjects OR, RN license or foreign medical graduates with at least 3 years’ experience in research coordination.
Other Required Qualifications
Previous experience consenting patients in medical setting
Knowledge of clinical trial research rules and regulations
Demonstrated diplomacy with physicians, other medical and administrative staff
Ability to see overall picture and be an advocate for patients as well as an effective research advocate
Demonstrated ability to successfully manage multiple clinical trials
Demonstrated ability managing staff
Credentialing as a Clinical Research Coordinator.
Strong interpersonal skills with people from different backgrounds
Demonstrated proficiency with Microsoft Word and Excel
Strong organizational skills
Effective communication skills, oral and written
Master’s degree in public health, life sciences or similar
BSN training and 5-7 years’ experience in research study coordination with human subjects.
Experience in industry sponsored research in a medical setting.
2-3 years' experience as a manager and/or supervisor
Experience with budget development and monitoring/maintenance
Experience with human subject applications;
Familiarity with the ethical principles of clinical research including issues of patient and sponsor confidentiality
Ability to work occasional evenings and weekends
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.
Founded in 1861, the University of Washington is one of the oldest public institutions in the west coast and one of the preeminent research universities in the world. The University of Washington is a multi-campus university comprised of three different campuses: Seattle, Tacoma, and Bothell. The Seattle campus is made up of sixteen schools and colleges that serve students ranging from an undergraduate level to a doctoral level. The university is home to world-class libraries, arts, music, drama, and sports, as well as the highest quality medical care in Washington State and a world-class academic medical center. The teaching and research of the University’s many professional schools provide undergraduate and graduate students the education necessary toward achieving an excellence that will serve the state, the region, and the nation. As part of a large and diverse community, the University of Washington serves more students than any other institution in the Northwest.