"Alerted.org

Req #: 246399

Department: DEPARTMENT OF MEDICINE: GASTROENTEROLOGY

Job Location Detail: Hybrid

Posting Date: 05/27/2025

Closing Info:

Closes On 06/03/2025

Salary: $5,000 - $6,600 per month

Limited Recruitment: **Open to UW Employees only**

Shift: First Shift

Notes:

As a UW employee, you will enjoy generous benefits and work/life programs. For a complete description of our benefits for this position, please visit our website, click here. (https://hr.uw.edu/benefits/wp-content/uploads/sites/3/2018/02/benefits-professional-staff-librarians-academic-contract-covered-exempt-20250130-a11y.pdf)

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 Medicine: Gastroenterology has an outstanding opportunity for a Research Coordinator to join their team.** **POSITION PURPOSE

The Research Coordinator position exists to support and manage the implementation of complex clinical and observational research studies involving patients with Inflammatory Bowel Disease (IBD) within the GI Division. Under the general supervision of the Research Manager and Principal Investigator, this position plays a key role in facilitating high-quality, compliant, and methodologically sound research that advances the division’s academic and clinical missions.

The Research Coordinator independently oversees daily research operations, including participant recruitment, data collection, and protocol adherence, while contributing to the scientific development of studies through input on hypothesis development, study design, data analysis, and interpretation of findings. The role is essential in defining research problems, refining methodological approaches, and supporting the creation of publishable scholarly work.

In addition to managing study execution, the coordinator assists in securing funding by supporting grant applications, preparing IRB submissions, negotiating contracts, and ensuring that all research activities conform to institutional, federal, and sponsor-specific regulations. This position may also be responsible for training junior staff, refining workflows, and contributing to quality improvement initiatives related to research operations.

By providing both operational and scientific support, the Research Coordinator contributes significantly to the development, growth, and regulatory compliance of the IBD research program.

POSITION COMPLEXITIES

The Research Coordinator position requires a high degree of independent judgment and specialized knowledge in the design, conduct, and management of complex clinical and observational research studies. The most demanding aspects of this role involve navigating and applying evolving FDA, IRB, and institutional regulatory frameworks while maintaining the integrity and scientific rigor of ongoing studies. The Coordinator must evaluate and make informed decisions regarding participant eligibility, protocol compliance, adverse event reporting, and ethical recruitment strategies—often in real time.

The position also demands the development and implementation of research strategies and digital data management tools tailored to the unique needs of IBD studies, including remote patient monitoring, biospecimen handling, and data collection. As studies increasingly span multiple institutions and data platforms, the Coordinator must adapt methods and processes to ensure accuracy, consistency, and compliance across diverse clinical environments.

Additionally, the role requires balancing scientific objectives with administrative and financial responsibilities. This includes contributing to the preparation of competitive research funding proposals, and negotiating budgets with sponsors—tasks that involve complex decision-making under tight deadlines. The Coordinator may also be responsible for training and mentoring junior staff or collaborators, including those at external research sites, adding a further layer of complexity to communication and oversight responsibilities.

POSITION DIMENSIONS AND IMPACT TO THE UNIVERSITY

This position plays a critical role in ensuring the University of Washington maintains its leadership in clinical research excellence. By integrating cutting-edge data management strategies and research methodologies, the Research Coordinator ensures compliance with FDA regulations while advancing the institution’s reputation in IBD research.

The Coordinator will assist in the daily operation of several multi-center trials to study inflammatory bowel disease, as well as additional planned future research studies in inflammatory bowel disease. This position will ensure that the Division not only complies with these regulations and policies but sets the standard of excellence in this area. This position will maintain an awareness of, and familiarity with, policies and procedures impacting the liability and responsibilities of the Division as it pertains to research, clinical care and education.

**DUTIES AND RESPONSIBILITIES** Protocol Management – 40%

+ Independently implement and oversee the execution of research project protocols to meet objectives, ensuring adherence to all institutional, federal, and study sponsor regulations and guidelines. This includes managing the end-to-end lifecycle of multiple clinical trials, from initiation through close-out, which include obtaining study approval.

+ Identify and define research problems related to Inflammatory Bowel Disease (IBD) and broader GI research, applying advanced methodologies, such as study design, data collection, analysis and interpretation, tailored to clinical and observational study designs.

+ Assist in development study hypotheses and methodologies for randomized controlled trials, case-control studies, and registry-based research within the GI clinic. Collaborate with principal investigators and clinical teams to refine research questions and translate clinical observations into testable hypotheses relevant to Inflammatory Bowel Disease.

+ Direct the recruitment, screening, and enrollment of study participants, ensuring eligibility criteria are met and maintaining a positive patient experience throughout the trial.

+ Develop, standardize, and maintain detailed operational procedures for patient registration, study execution, and protocol compliance, aligning with Good Clinical Practice (GCP) standards to ensure ethical and high-quality research.

+ Coordinate and conduct study visits and related activities, ensuring accurate and timely data collection, documentation, and data entry into relevant systems. Maintain meticulous study source records and promptly address queries or discrepancies identified in source documentation.

+ Support regulatory compliance by partnering with the Regulatory Coordinator to design study-specific tools and templates, prepare and submit regulatory documentation, and maintain organized regulatory binders for Institutional Review Boards (IRBs), Data Safety Monitoring Boards, and other governing bodies.

+ Monitor trial progress by maintaining oversight of timelines, deliverables, and milestones while ensuring that all research team members meet required deadlines. Identify and address operational barriers to ensure that studies remain on track.

+ Facilitate training and orientation for new research staff and investigators to ensure protocol understanding and compliance with institutional and regulatory requirements.

+ Collaborate with cross-functional research teams, including regulatory coordinators, research assistants, principal investigators, and external sponsors, to ensure successful execution and completion of clinical trials that meet research objectives and to standardize data collection methodologies and refine operational workflows across multiple GI research studies.Participant and Data Management – 40%

+ Coordinate and oversee all aspects of participant management, scheduling and tracking study-related visits, tests, and procedures according to protocol requirements. Ensure billing compliance while maintaining accurate and complete data collection, such as informed consent forms, source documentation, and study-specific documentation.

+ Extract, abstract, and code clinical data from various sources (e.g., medical records, research records) to ensure accurate and timely entry into study-specific data capture systems. This includes verifying the consistency of data with protocol requirements and resolving discrepancies as needed.

+ Monitor and document adverse events, safety concerns, and protocol deviations, ensuring they are promptly reported to investigators, sponsors, Institutional Review Boards (IRBs), and other relevant regulatory authorities.

+ Act as the liaison for study sponsors and monitors during site visits. Prepare for these visits by ensuring the availability of accurate and up-to-date study documentation, addressing action items, and facilitating follow-up discussions.

+ With minimal oversight, design and implement corrective action plans to maintain protocol adherence and data integrity. Collaborate with the research team to ensure queries and data discrepancies are resolved in a timely and efficient manner, enhancing the quality of study data.

+ Develop and maintain tools to streamline data collection and patient tracking processes, leveraging technology and collaborative solutions to improve data accuracy and efficiency.

+ Contribute to the analysis and interpretation of study data, assist in the development of evidence-based, publishable conclusions, and review abstracts and manuscripts prior to submission for publication or presentation by collaborating with investigators and data analysts to review study findings, participating in the synthesis of study results into coherent conclusions that reflect the research objectives, methodology, and clinical significance and supporting the preparation of abstracts, posters, and manuscripts by reviewing content for accuracy and clarity.Administrative and Stakeholder Communication – 20%

+ Maintain a strong understanding of assigned study protocols, including detailed knowledge of patient populations, relevant diseases, and the operations of clinical service lines. This comprehensive knowledge ensures effective oversight and seamless study execution.

+ Facilitate effective communication with a wide range of stakeholders, including sponsors, sponsor affiliates, investigators, clinical staff, and participants. Regularly provide updates, address inquiries, and maintain positive working relationships to support study success.

+ Independently manage a diverse portfolio of clinical projects, balancing competing priorities and adhering to strict timelines and deadlines. This requires a high level of organization, adaptability, and decision-making under pressure.

+ Serve as a resource for team members by providing guidance on protocol specifics, offering solutions to logistical challenges, and fostering a collaborative work environment that aligns with study goals and objectives.

+ Maintain detailed and organized documentation for all study-related activities, ensuring compliance with institutional and regulatory standards. This includes maintaining trackers for assigned projects, timelines, and coordinator roles, ensuring all stakeholders have access to up-to-date information.

+ Implement process improvements based on feedback and lessons learned from previous studies, continuously enhancing administrative and operational workflows to optimize efficiency and study outcomes.

+ Negotiate clinical trial budgets and research contracts with sponsors while ensuring compliance with FDA regulations.

+ Secure and manage research supplies, laboratory equipment, and essential study resources to support ongoing GI clinical trials and observational studies. **MINIMUM REQUIREMENTS**

+ Bachelor’s degree in biological sciences or a related field or equivalent combination of education and experience.

+ At least two years of experience in clinical research.

+ Advanced knowledge of clinical trial design, data management strategies, and implementation of research methodologies. **Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.** **DESIRED QUALIFICATIONS**

+ Minimum of two years experience with multiple sponsored clinical trial and investigator initiated studies.

+ Must have knowledge of medical terminology and hospital procedures.

+ Experience in the health care field required.

+ Prior experience working in an academic research setting.

+ Experience interacting with patients, physicians and nurses. Experience with laboratory procedures.

+ Experience with multiple sponsored clinical trials and investigator initiated studies. Knowledge in clinical trial processes, and implementation of research protocols. **WORKING ENVIRONMENTAL CONDITIONS:** This role requires availability to address research-related concerns in real time, including urgent adverse event reporting and data security monitoring. The position involves working in diverse environments, including clinical settings, laboratories, and remote data management platforms. **Application Process:** The application process may include completion of a variety of online assessments to obtain additional information that will be used in the evaluation process. These assessments may include Work Authorization, Cover Letter and/or others. Any assessments that you need to complete will appear on your screen as soon as you select “Apply to this position”. Once you begin an assessment, it must be completed at that time; if you do not complete the assessment, you will be prompted to do so the next time you access your “My Jobs” page. If you select to take it later, it will appear on your "My Jobs" page to take when you are access ready. Please note that your application will not be reviewed, and you will not be considered for this position until all required assessments have been completed.\#UWDeptMedicineJobs

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.