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.
UW Medicine works to improve the health of the public by advancing medical knowledge, providing outstanding primary and specialty medical care to people of the region, and preparing tomorrow’s physicians, scientists and other health professionals. Within the large UW Medicine health system, the School of Medicine (SOM) is a world leader in biomedical research, with the largest biomedical research program at a public university based on National Institutes of Health funding and ranking among the top research universities internationally.
The Clinical Trials Office Research Coordination Center has an outstanding opportunity for a Lead Research Coordinator.
The Clinical Trials Office (CTO) supports the clinical research mission of UW Medicine. The CTO is an operational unit within the SOM’s Office of Research and Graduate Education charged with providing multi-service support to clinical researchers bringing important new therapies to our patients in compliance with evolving regulatory requirements.
The Research Coordination Center (RCC) is a unit of the CTO that offers support to help investigators improve the quality of their research and ensure compliance with federal and state regulations, ICH GCP guidelines and institutional policies. The RCC serves clinical researchers from the six UW Health Science schools as well as those from partner institutions. The RCC staff assist with both investigator-initiated biomedical or behavioral studies and pharmaceutical industry sponsored clinical trials. The CTO RCC offers regulatory support and study coordination, trial start-up, internal monitoring and quality assurance, and other services.
Team Lead: • Under the direction of the CTO RCC Research Manager assign and distribute administrative start-up and regulatory workload of new and current clinical research studies. This includes both the continual assessment of the workload for ongoing studies based on team capacity and project needs and the redistribution of work as needed. • Provide support and mentorship to the RCC regulatory coordinators with a focus on delivering quality data while maintaining defined project timelines and priorities. • Provide quality assurance oversight for the regulatory portfolio. Ensure that work is performed to all standards for data quality, regulatory compliance, and research participant safety. • Ensure customer satisfaction by establishing and maintaining positive relationships and open communication with Principal Investigators and their departmental liaisons, as well as sponsors and CROs. • Perform intake of new regulatory and start-up service requests with investigators to assess study needs and requirements, provide cost estimates and execute service agreements. • Evaluate feedback and complaints about CTO RCC regulatory services and mitigate any concerns and report to the Research Manager as appropriate. • Facilitate annual assessment of regulatory staff performance and assist with other HR-related functions, including hiring and onboarding of new staff, performance management, etc. • Contribute to development of training materials, standard operating procedures (SOPs), quality improvement systems. • Assist CTO RCC Research Manager with staff meetings, team huddles and ongoing training for RCC staff.
Regulatory Coordination: • Provide full spectrum of clinical trial regulatory services to principal investigator clients and their research teams, including study startup, FDA IND/IDE submissions, IRB, IBC and other institutional review and approval submissions, regulatory oversight and study regulatory binder management, regulatory close-out, etc. • Manage regulatory requirements for both investigator-initiated and industry sponsor-initiated trials and research studies, typically working on multiple research protocols at the same time. • Oversee regulatory aspects of protocol implementation in compliance with Federal regulations, ICH GCP guidelines, IRB-approved protocol requirements, State laws, and institutional policies. • Collaborate with budget and contract colleagues to properly align study protocols and protocol amendment impacts. • Consult with investigators and study coordinator staff/colleagues on regulatory requirements pertaining to their studies. • Prepare for any sponsor, FDA, IRB or other agency-initiated audits and inspections. • Develop and help implement Corrective and Preventive Action (CAPA) plans.
MINIMUM REQUIREMENTS • Bachelor’s degree in science, healthcare or related field or an equivalent combination of education and experience. • At least four years of experience as a research coordinator working on both PI-initiated and industry-initiated clinical trials.
Additional Requirements: • Experience working in academic medical center environment and familiarity with electronic medical records systems. • Ability to manage competing priorities with minimal direction. • Demonstrated skills in MS Office software. • Excellent written communication skills and ability to draft complex correspondence. • Outstanding verbal and interpersonal communication skills to be able to interact effectively with leadership, faculty, research staff, sponsors, and study participants. • Skill and ability in managing confidential information and processes. • Ability to work effectively and efficiently in a team setting in a fast-paced environment.
Equivalent education and/or experience may substitute for minimum requirements.
DESIRED REQUIREMENTS • Current professional ACRP or SOCRA certification (CCRA, CCRC or CCRP). • Experience coordinating clinical trials within the University of Washington. • Experience working in Epic EHR. • Previous experience mentoring and/or supervising research coordinator staff.
CONDITIONS OF EMPLOYMENT 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.