Research Coordinator Supervisor

Job Description

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.

About this Opportunity

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.

Key Responsibilities

40% Research Coordinator Duties

• Research Study Management:
  • 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 Administrations 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
• Research Data Management
  • 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).
• Patient/Participant Management:
  • 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 patients care
  • Ensure compliance with research protocol
  • Inform referring physicians of protocol requirements
  • Perform other duties as required

20% CRU Operations and Program Leadership

• 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.

20% Staff Supervision

• 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.

20% Study Oversight

• 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.

Required Qualifications

To be considered for this opportunity your application must demonstrate you meet both the minimum qualifications and additional qualifications listed below. Equivalent education and/or experience may substitute for minimum qualifications except when there are legal requirements such as a license certification and/or registration.

Minimum Qualifications

• Bachelors degree in science or health related field and four years of relevant experience in clinical research.
• Applicants who do not meet these qualifications WILL NOT be forwarded to the Hiring Manager.

Additional Qualifications

• 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

• Applicants selected for this position who have not already completed the training for clinical research involving human subjects will be required to complete it within 90 days of hire

Preferred Qualifications

• 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.

Working Conditions

• Office and participant visit location in the UW Diabetes Institute F Building.

• May require climbing stairs to access office location.

• Must have flexibility to meet programmatic needs by adjusting work schedule

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Compensation Benefits and Position Details

Pay Range Minimum:

Pay Range Maximum:

Other Compensation:

Benefits:

Temporary or Regular

FTE (Full-Time Equivalent):

Union/Bargaining Unit:

About the UW

Working at the University of Washington provides a unique opportunity to change lives on our campuses in our state and around the world.

UW employees bring their boundless energy creative problem-solving skills and dedication to building stronger minds and a healthier return they enjoy outstanding benefits opportunities for professional growth and the chance to work in an environment known for its diversity intellectual excitement artistic pursuits and natural beauty.

Our Commitment

The University of Washington is committed to fostering an inclusive respectful and welcoming community for all. As an equal opportunity employer the University considers applicants for employment without regard to race color creed religion national origin citizenship sex pregnancy age marital status sexual orientation gender identity or expression genetic information disability or veteran status consistent with UW Executive Order No. 81.

To request disability accommodation in the application process contact the Disability Services Office at or .

Applicants considered for this position will be required to disclose if they are the subject of any substantiated findings or current investigations related to sexual misconduct at their current employment and past employment. Disclosure is required under Washington state law.