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Job Description

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.

The** **Department of Dermatology** **has an outstanding opportunity for a** **MC3 Institute Trials Coordinator (Research Coordinator 2)** **to join their team.

The Clinical Trial Coordinator at the MC3 Institute will coordinate approximately four multi-site oncology research studies with a focus on protocol start-up, regulatory compliance, data integrity, and study oversight. This role supports the successful execution of investigator-initiated and cooperative group trials in collaboration with national and institutional partners. The coordinator will work closely with principal investigators, clinical staff, regulatory offices, and external collaborators to ensure studies are efficiently managed from activation through closure. This position reports to the Director of People & Programs, with a dotted line to the Faculty Director of the MC3 Institute.

This is a hybrid role based out of Seattle.

DUTIES AND RESPONSIBILITIES

_Regulatory & Compliance Oversight (25%)_

+ Prepare and submit regulatory documents (protocols, amendments, consents, reports) to IRBs and oversight bodies.

+ Manage start-up and amendment submissions, communications, and site updates.

+ Maintain audit-ready regulatory binders, monitoring plans, and study communications.

+ Serve as regulatory liaison for study teams, sponsors, monitoring agencies, and institutional offices.

+ Monitor data entry after enrollment, conduct real-time QC of case reports, and perform database exports.

_Ongoing Coordination & Communication (25%)_

+ Prepare meeting materials, gather data, and create presentations.

+ Contribute to meetings, take notes, and track action items.

+ Coordinate scheduling, including creation and troubleshooting of calendar invites.

+ Maintain participant records and ensure timely communication with new members.

+ Develop and implement streamlined workflows (templates, checklists, schedules).

+ Conduct regular reviews to ensure audit readiness and resolve outstanding queries.

+ Support database management, cleanup, and coordination with investigators.

+ Respond to inquiries, issue reminders, and provide team updates.

+ Occasional work may be required outside normal business hours.

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_Data & Scientific Support (20%)_

+ Develop and implement strategies for real-time data monitoring and resolution of delays.

+ Participate in data reviews and assist with query resolution using Theradex and RAVE.

+ Coordinate data exports and generate analysis-ready datasets for reporting and regulatory use, including partnership with the Honest Broker program as appropriate.

+ Collaborate on manuscript preparation and submission to sponsoring agencies (e.g., NCI).

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_Study Start-up & Protocol Implementation (15%)_

+ Support study design, protocol development, and selection of research methods.

+ Develop standardized documentation and tools (e.g., guidelines, Case Report Forms (CRFs), consent forms).

+ Lead participant recruitment and eligibility assessments, including outreach to clinics and physicians, and partnership with the Honest Broker program in identifying cohorts.

+ Oversee protocol implementation, ensuring accuracy, quality, and resolution of operational challenges.

+ Contribute to grant applications (recruitment, human subjects, and data dissemination sections).

+ Serve as liaison between study teams and regulatory offices to ensure timely activation.

_Progress Reporting & Study Closure (15%)_

+ Prepare and submit quarterly progress surveys to NCI.

+ Draft and submit CIRB continuing review applications and change-of-status memos.

+ Update RSS and ClinicalTrials.gov with study status and results.

+ Generate reports and datasets for ClinicalTrials.gov reporting and publications.

+ Ensure compliance with federal requirements for ClinicalTrials.gov entries.

MINIMUM REQUIREMENTS

+ Bachelor’s degree in related field (health or scientific) and two years of relevant experience.

_Equivalent education and/or experience may substitute for minimum qualifications except when there are legal requirements, such as a license, certification, and/or registration._

DESIRED QUALIFICATIONS

+ Experience in clinical trial coordination, particularly regulatory and data-focused tasks.

+ Working knowledge of FDA submissions, including but not limited to Investigational New Drug applications (INDs), New Drug Applications (NDAs), Biologics License Applications (BLAs), as well as regulatory reporting requirements.

+ Strong organizational, communication, and collaboration skills; ability to work independently and in a team.

+ Knowledge of clinical research, human subjects' protections, and regulatory requirements.

+ Prior experience with NCI-funded or cooperative group oncology trials.

+ Experience with ClinicalTrials.gov submissions and reporting.

+ Working knowledge of federal research regulations and Good Clinical Practice (GCP) guidelines.

+ Demonstrated ability to ensure data integrity and contribute to publication of study results.

Compensation, Benefits and Position Details

Pay Range Minimum:

$56,832.00 annual

Pay Range Maximum:

$85,992.00 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

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 world. In 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 proud to be an affirmative action and equal opportunity employer (https://hr.uw.edu/eoaa/) . All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, national origin, age, protected veteran or disabled status, or genetic information.

To request disability accommodation in the application process, contact the Disability Services Office at 206-543-6450 or [email protected] .

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 (https://app.leg.wa.gov/RCW/default.aspx?cite=28B.112.080) .

University of Washington is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to, among other things, race, religion, color, national origin, sexual orientation, gender identity, sex, age, protected veteran or disabled status, or genetic information.