Job Description

The Division of Allergy and Infectious Diseases, Positive Research, has an outstanding opportunity for a Research Coordinator 4 to join their team.

About this Opportunity

Reporting to the Program Manager, the Research Coordinator 4 provides senior-level coordination and regulatory support for the UW Positive Research clinical trials portfolio. The position will oversee and manage complex clinical research activities across NIH network and industry-sponsored studies, with particular responsibility for study start-up, ongoing regulatory management, sponsor requirements, and coordination of clinical trial operations.

The role will support UW Positive Research's expanding portfolio of HIV and other clinical trials by ensuring that studies are implemented and maintained in accordance with protocol requirements, sponsor expectations, institutional policies, and applicable regulatory standards. The position will work closely with investigators, research staff, sponsors, and external partners to support the successful initiation and ongoing management of multiple concurrent clinical trials.

UW Positive Research currently manages a diverse portfolio that includes NIH network studies and multiple industry-sponsored clinical trials with several external sponsors.

Key Responsibilities

Regulatory Oversight & Compliance Management (35%)

• Oversee the development, submission, and maintenance of regulatory documents required for clinical research, including IRB applications, continuing reviews, modifications, and reportable events.
• Ensure compliance with federal, state, and institutional regulations (e.g., FDA, OHRP, ICH GCP, UW policies).
• Serve as the primary subject matter expert on regulatory requirements for the unit.
• Oversee regulatory timelines and ensure all approvals are current and accurate.

Study Activation & Documentation Coordination (20%)

• Oversee regulatory start up activities, including protocol review, regulatory binder creation, and coordination of required institutional approvals.
• Maintain accurate and audit ready regulatory files (electronic and paper). Insuring version control and management of procedure documents. Procedural documents and tracking; communications to the teams the various versions.
• Coordinate with investigators, study teams, and institutional offices to ensure timely study activation.

Training, Guidance & Lead Responsibilities (15%)

• Provide day-to-day guidance, training, and workflow support to regulatory staff and study team members.
• Assign, organize, and review regulatory work in alignment with lead worker responsibilities (training, scheduling, reviewing work; no hiring or disciplinary authority).
• Develop and update standard operating procedures (SOPs) and best practices.

Quality Assurance & Audit Support (15%)

• Conduct internal quality checks of regulatory documents for accuracy, completeness, and compliance.
• Prepare for and support internal and external audits, monitoring visits, and inspections.
• Identify compliance risks and recommend corrective and preventive actions.
• Serve in an advisory role to research staff on regulatory and compliance issues.

Stakeholder Communication & Collaboration (10%)

• Serve as a liaison between investigators, study teams, IRB offices, sponsors, and regulatory agencies.
• Communicate regulatory requirements, timelines, and updates to stakeholders.
• Participate in unit meetings and cross functional working groups.

Data & Systems Management (5%)

• Manage the development of data collection methods, systems, tools and materials.
• Implement and supervise data collection activities at a senior level.
• Develop and implement quality assurance protocols with senior authority.
• Maintain regulatory tracking systems, databases, and dashboards.
• Ensure accurate entry of regulatory milestones and documentation into institutional systems.

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

Applicants who do not meet these qualifications WILL NOT be forwarded to the Hiring Department.

• Master's Degree in any field of science, communications, or pre-medical/nursing/pharmacy or related field and four years of experience in a clinical research setting.

Additional Qualifications

• Experience with regulatory reporting requirements and platforms at UW including Florence eBinder, OnCore CTMS, UW Zipline and Advarra CIRBI.
• Experience working with NIH-funded research, including regulatory requirements for conducting NIH-funded clinical trials.
• Experience working with Industry research including FDA regulatory requirements.

Preferred Qualifications

• Experience with DAIDS Reporting system CRMS for site registration, DAIDS Score Manual and DAIDS requirements for maintaining regulatory operations.

Working Conditions

• Constantly changing priorities as various sponsor requests for information or new/ updated protocol information requiring implementation within 24 hours can impact planned work.
• Hybrid remote and in-person work depending on the workload needs will shift from week to week.

About the Team

UW Positive Research supports a complex and growing portfolio of NIH network and industry-sponsored clinical trials focused on HIV and other areas of clinical research. As of March 2026, the unit supports 23 studies: 8 in startup, 6 with active participant activity, and 9 in post-participant follow-up still open with the IRB.

UW Positive Research is the only UW-Fred Hutch site conducting interventional studies for HIV treatment, HIV cure, and related co-morbidities. The unit also serves as a shared clinical trials resource for investigators studying HIV, hepatitis, and substance use disorders who lack their own trials unit or staff. The team includes 12 standing staff, supports up to 6 additional faculty investigators at a time, and operates on an annual budget of about $4 million.

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Compensation, Benefits and Position Details

Pay Range Minimum:
$90,156.00 annual
Pay Range Maximum:
$156,684.00 annual
Other Compensation:

Benefits:
For information about benefits for this position, visit https://www.washington.edu/jobs/benefits-for-uw-staff/
Shift:
First Shift (United States of America)
Temporary or Regular?
This is a regular position
FTE (Full-Time Equivalent):
100.00%
Union/Bargaining Unit:
UAW Research