Research Coordinator 4 (E S UAW Research)

Job Description

The Department of Ophthalmology has an outstanding opportunity for Research Coordinator 4 to join their team.

OVERVIEW:

Reporting to the Associate Director of Research the Research Coordinator 4 serves as the subject matter expert on the full scope of clinical research education management and compliance for the entire Department of Ophthalmology at the University of Washington. The Research Coordinator 4 with collaborate with the Associate Director of Research to oversee educational programs that span the entire scope of clinical research operations including training trial start-up study management regulatory compliance financial operations and billing practices.

The Research Coordinator 4 provides strategic leadership oversight and operational management of regulatory affairs and research compliance activities supporting clinical research programs at the University of Washington (UW). This position ensures that all clinical research activities are conducted in accordance with federal state local sponsor and institutional requirements including regulations governing human subjects research FDA-regulated studies Good Clinical Practice (GCP) and institutional review board (IRB) oversight.

The Research Coordinator 4 serves as the departments subject matter expert in clinical research regulation compliance education and operations partnering with investigators study teams sponsors and institutional stakeholders to ensure research excellence and regulatory compliance.

The Research Coordinator 4 provides strategic leadership for regulatory affairs and research compliance programs including regulatory submissions compliance monitoring personnel supervision and corrective action initiatives supporting clinical research across the Department of Ophthalmology.

RESPONSIBILITIES:

Clinical Research Regulatory Management and Oversight (30%)

Independently coordinate and oversee regulatory and compliance activities for complex investigator-initiated and/or industry-sponsored clinical research studies exercising professional judgment in interpreting institutional federal and sponsor requirements.

Manage regulatory submissions including:

- Initial IRB applications

- Continuing reviews

- Modifications and amendments

- Reportable events

- Safety reports

- Study closures

Maintain complete and audit-ready regulatory documentation including TMFs and records within OnCore and other regulatory systems.

Develop and disseminate standardized tools templates and job aids to support all operational phases of clinical research from start-up to close-out.

Obtain and maintain IRB approvals including initial submissions continuing review protocol modifications amendments and study closures.

Report and document safety issues (e.g. adverse events) to the applicable oversight body.

Prepare for and participate in sponsor audits and/or regulatory inspections if applicable.

FDA Investigational New Drug and Device Exemption (IND/IDE) application support.

Serve as the primary regulatory liaison for investigators study teams sponsors and oversight bodies.

Research Compliance Program Management (30%)

Coordinate and support the development implementation and continuous improvement of research compliance processes and programs supporting clinical trials and human subjects research.

Develop implement and maintain research compliance programs supporting clinical trials and human subjects research.

Evaluate study activities for adherence to:

- FDA regulations

- OHRP requirements

- HIPAA regulations

- Good Clinical Practice (ICH-GCP)

- University of Washington policies

- Sponsor requirements

Track compliance metrics and prepare reports for departmental and institutional leadership.

Lead compliance monitoring risk assessments audits (sponsor FDA NIH OHRP institutional) and inspection-readiness activities; manage findings CAPA plans and reporting to ensure ongoing adherence to regulatory and institutional requirements.

Clinical Research Operations Support (20%)

Collaborate with investigators and study teams on protocol development study start-up activities and preparation of related study documentation.

Review protocols informed consent documents and ancillary materials for regulatory compliance.

Assist in developing standard operating procedures (SOPs) and work instructions.

Support study initiation monitoring visits sponsor audits and regulatory inspections.

Training Delivery & Assessment (10%)

Design oversee and deliver role-based clinical research training programs for faculty and staff ensuring alignment with institutional sponsor and regulatory requirements.

Develop and maintain training matrices tracking systems competency assessments and needs analyses to monitor compliance and workforce development.

Ensure training reflects current FDA cGCP cGMP NIH CMS billing rules and institutional guidelines.

Communicate timely regulatory changes and operational updates to research teams through multiple channels including presentations workshops and reference materials.

Strategic Planning and Continuous Improvement (5%)

Foster a culture of accountability quality compliance and continuous improvement through staff development process optimization and adoption of best practices.

Participate in institutional committees and working groups.

Contribute to strategic planning efforts supporting UW clinical research programs.

Leadership (5%)

Supervise regulatory specialists compliance coordinators research coordinators and related research support staff.

Serve as a resource and mentor for study team regarding regulatory best practices.

Collaborate with the UW regulatory offices research administration and external partners to leverage resources and share best practices.

Other duties as assigned.

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:

Masters degree in Clinical Research Administration Health Care Administration Regulatory Science or a related field.

Four (4) years of progressively responsible experience in clinical research regulatory affairs research compliance or related healthcare environment.

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

ADDITIONAL QUALIFICATIONS:

Advanced knowledge of FDA GCP NIH OHRP HIPAA and other applicable clinical research regulations.

Demonstrated experience managing regulatory submissions research compliance programs audits inspections and regulatory documentation.

Experience supporting investigator-initiated studies and FDA IND/IDE submissions.

Experience developing and delivering research education and training programs.

Experience using electronic IRB systems CTMS platforms and other research regulatory systems.

Demonstrated leadership project management and personnel supervision experience.

Excellent written verbal and interpersonal communication skills.

Demonstrated ability to exercise independent judgment manage multiple priorities and handle confidential information with discretion.

Proficiency with:

- Microsoft Office Suite

- Electronic IRB systems

- Clinical Trial Management Systems (CTMS)

- Electronic regulatory platform

DESIRED QUALIFICATIONS:

At least 5 years of management experience working in an academic medical center or a clinical research organization.

Professional certification such as:

- Certified Clinical Research Professional (CCRP)

- Certified Clinical Research Coordinator (CCRC)

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.