Research Coordinator Supervisor

University of Washington•Seattle, WA

1d•Onsite

About The Position

The Division of Metabolism, Endocrinology and Nutrition (MET) has an outstanding opportunity for a Research Coordinator Supervisor position to join the Diabetes Institute Clinical Research Unit (CRU). The Diabetes Institute Clinical Research Unit is a research facility dedicated to the conduct of human studies of diabetes and related disorders. We provide a variety of study support services including facility and room use, research coordinator support, research nursing or mid-level provider support, blood draws, clamp services, and performance of body composition by DXA. Reporting to the CRU Director, this position will supervise the Research Coordinator team and is also responsible for developing and maintaining ongoing support for clinical studies within the unit. Under the supervision of the medical director, the research coordinator supervisor will coordinate and supervise the performance of clinical research procedures conducted within the CRU and provide comprehensive research support, including clinical trials consulting, regulatory guidance, and research coordination for UWMDI CRU-based studies. They will follow research protocols to obtain data through interviewing subjects/patients, conducting laboratory tests, following research protocols, coordinate patient participation in medical research studies and compile and verify the accuracy of research data.

Requirements

Bachelor’s degree in science or health related field and four years of relevant experience in clinical research.
Experience in research compliance
Sound knowledge of IRB submission procedures, FDA, GCP, and NIH requirements relating to research involving human subjects
Prior working experience with common eCRF systems (e.g., Inform, Medidata, Medrio, etc.)
Knowledge of OnCore CTMS software
Strong computer skills and competency with Microsoft Office software
Strong attention to detail and ability to multi-task, organize and prioritize multiple projects
Experience in clinical trial processes and implementation of research protocols
Demonstrated ability to work independently with minimal supervision
Ability to communicate effectively both verbally and in writing, and to work effectively with colleagues and study sponsor representatives

Nice To Haves

Experience or knowledge working in a clinical setting.
3 plus years of experience in research compliance.
Certification in Good Clinical Practice.
Human subjects ethics training.
DMID source document and regulatory document training, HIPAA and other clinical research training.
Experience with EPIC/ORCA/MINDSCAPE/MAX/LIS record systems.

Responsibilities

Coordinate the operations of clinical, biomedical, and/or behavioral research studies involving human subjects
Coordinate specialized tasks with the research team such as the operation of equipment, processing of laboratory specimens, administering of treatment and/or medication in accordance with research protocol, assessment of patient reaction to medications and/or treatments as part of a research protocol and identification of potential adverse reactions
Perform certain non-invasive patient-oriented procedures
Responsible for the processing and shipping of study-specific laboratory specimens
Coordinate physician examinations and study protocol for technicians
Assist in planning aspects of team research
Keep study files in compliance with Food and Drug Administration's regulations
Read, interpret and communicate protocol for clinical studies providing data on the safety and efficacy of new drugs
Establish and maintain effective working relationships with patients and their families, professional or community groups and volunteers
Maintain contact with Principal Investigators, Co-Investigators, and public agencies which are involved with aspects of the research
Maintain records of study data.
Design data collection tools.
Obtain and record research data in conjunction with physician and other professionals on the research team.
Assist in preparing interim reports for Principal Investigators, Study Sponsor and Human Subjects Review Board to ensure that each project timeline is being met.
Communicate with Principal Investigators, pharmaceutical and equipment company medical personnel in handling results of studies (progress reports, case report forms).
Screen, recruit and interview potential subjects to determine eligibility according to specific study protocols
Obtain informed consent
Enroll patients in research protocol
Explain research protocol to participants
Respond to patient inquiries regarding protocol
Schedule patient participation
Coordinate all aspects of the patient's care
Ensure compliance with research protocol
Inform referring physicians of protocol requirements
Perform other duties as required
Directs day to day operations of the CRU, including staffing, scheduling, and resource allocation.
Assists the CRU Director in the organization, strategic planning, and overall direction of CRU research programs.
Ensures operational compliance with institutional policies, federal regulations, and clinical research best practices.
Leads development and implementation of workflow improvements to enhance CRU efficiency, throughput, and participant experience.
Monitors operational metrics and produces routine reports to inform leadership decisions.
Serves as a primary liaison between CRU staff, investigators, clinical departments, and administrative units to support cross-unit coordination.
Participates in long term planning discussions, including evaluation of new research service offerings, equipment needs, and process innovations.
Supervises Research Study Coordinators and volunteers.
Leads recruitment activities, including developing job postings, interviewing, and recommending candidates for hire.
Oversees onboarding, training, work assignment, scheduling, leave management, performance evaluations, and disciplinary recommendations.
Oversees the work of CRU Research Study Coordinators across regulatory activities and approvals, protocol development, study procedures, participant recruitment, study visit execution, and quality assurance activities including development of CRU standard operating procedures.
Familiar with all active studies to allow coverage as a backup study coordinator when needed.
Coordinates per diem RN schedule and hiring.
Ensures staff maintain required competencies and annual certifications, including research compliance and safety training.
Facilitates regular staff meetings, team communication, and continuing education opportunities.
Provides coaching, mentorship, and professional development planning to support staff career advancement.
Conducts workload analyses to ensure equitable distribution of tasks and operational coverage.
Addresses interpersonal or workflow conflicts using appropriate problem solving and HR-supported approaches.
Promotes an inclusive, supportive, and high-performance team culture aligned with organizational values.
Directs study record keeping and data collection processes, ensuring data accuracy, integrity, and quality control.
Manages maintenance of equipment and supplies.
Develops and provides cost estimates for investigators utilizing CRU services
Collaborates with investigators, new investigators, and the CRU Director to obtain regulatory approval for industry sponsored and federally funded research.
Tracks CRU usage and generates monthly invoices in coordination with the CRU Director and UWMDI Program Manager.
Assists investigators in feasibility assessments and pre award operational planning for proposed studies.