Research - Laboratory/Non-Laboratory, Staff/Administrative
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The Clinical Trials Office Research Coordination Center has an outstanding opportunity for a Lead Research Coordinator to support the study coordination operations and administration of the center. The responsibilities of this position will encompass both Lead and study coordination activities.
The Lead Research Coordinator will oversee the CTO RCC study coordination portfolio of clinical trials and research studies and will ensure their compliance with GCP, HIPAA, IRB, FDA and the University policies. The Lead Coordinator will provide mentorship and support to the CTO study coordination team. They will also work directly with multiple principal investigators providing coordinating services for clinical trials. The position requires a high degree of flexibility and organization and the ability to work in a variety of settings and locations.
Team Lead: •Under the direction of the CTO RCC Research Manager assign and distribute study coordination workload of new and current clinical research studies to RCC staff. 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 study coordinators with a focus on delivering quality data while maintaining defined project timelines and priorities. •Provide quality assurance oversight for the study coordination 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 study coordination service requests with investigators to assess study needs and requirements, provide cost estimates and execute service agreements. •Evaluate feedback and complaints about CTO RCC study coordination services, mitigate any concerns, and report to the Research Manager as appropriate. •Facilitate annual assessment of study coordination 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), and quality improvement systems. •Assist CTO RCC Research Manager with staff meetings, team huddles and ongoing training for RCC staff.
Study Coordination: •Provide full spectrum of study coordination services to principal investigator clients and their research teams, including study preparation for coordination, participant screening and recruitment activities, scheduling and coordinating study visits, interacting with research participants, collecting and submitting study data, processing, handling and shipping research samples, coordinating sponsor monitoring visits, etc. •Coordinate both investigator-initiated and industry sponsor-initiated trials and research studies, typically working on multiple research protocols at the same time. •Effectively assess and execute study protocol requirements. •Oversee regulatory, budgetary, contractual and all other aspects of protocol implementation in compliance with Federal regulations, ICH GCP guidelines, IRB-approved protocol requirements, State laws, and institutional policies. •Appropriately document and report adverse events (AEs), serious adverse events (SAEs), and protocol deviations. •Prepare for and participate in sponsor, FDA, IRB or other agency-initiated audits and inspections.
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 (CCRC, CCRP or CCRA). •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.
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