Senior Research Coordinator Jobs

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.
POSITION PURPOSE
The University of Washington, Division of Medical Oncology has an excellent position for a Senior Research Coordinator in the Breast Cancer Research Program.
The purpose of this position is to promote the research objectives of the Breast Cancer Research Program in the Division of Oncology. This position works with the Research Manager, faculty, other research staff and clinical staff to facilitate pharmaceutical-sponsored and investigator-initiated clinical trials, identify research problems and design hypotheses to be tested. This position is responsible for independently designing and implementing multiple research projects to test the hypotheses in human subjects. This position will work closely with the Research Manager on process improvement and will serve as a resource to assist with training Research Coordinators and Research Assistants.
This position will work closely with the Research Manager in providing support for research projects, and will follow complex instructions for designing and implementing tools and methods to improve Breast Cancer Research Program clinical trial processes.
The mission statement of the University of Washington Medical Center states that the Medical Center serves as a research resource, providing an environment in which clinical research may be conducted. This position is essential to that mission.
This position must be able to work independently on multiple research projects without benefit of written policies or procedures. This position requires daily interaction with the Research Manager, research staff, physicians, other health care personnel (e.g. nurses, mid-levels), research staff at collaborating institutions, pharmaceutical company sponsors and any other groups integral to the successful completion of research projects.
DUTIES AND RESPONSIBILITIES
Protocol Coordination - 45%

Independently develop and implement research project policies and procedures that meet research objectives that ensure compliance with all aspects of Federal Drug Administration (FDA) and National Institutes of Health (NIH) regulations pertaining to clinical research in human subjects (e.g. investigator financial disclosure requirements of the FDA).

Design, develop, document and maintain policies and procedures for protocol registration and implementation to ensure that research execution meets good clinical practice guidelines.

Design, document and implement procedures for protocol audits to assure protocol compliance and to ensure research data quality.

Take action to correct problems such as deviation from protocol requirements to ensure research quality.

Ensure protocol compliance by managing patient appointments and coordinating with patient’s clinical providers (e.g. physicians, physician assistants, and nurses) to collect reliable and accurate data.

Ensure patient safety while participating in clinical trials by monitoring patients and interacting closely with patient’s clinical providers.
Research Program Support - 35%

Provide research manager with timely reporting of challenges that arise in clinical research (e.g., enrollment roadblocks, deviation trends, performance issues).

Lead activities designed to improve organizational performance.

Provide leadership in determining, recommending and implementing improvements to policies/processes; define best practices.

Manage coverage issues related to sick calls, vacation time, and may fill in to assist with responsibilities following a position vacancy.

May assist with the IRB submission, to include preparation of consent forms and other documents required for IRB review.

Help assess feasibility of new studies and troubleshoot study procedures/schedules.

Liaise with clinic management during development and execution of clinical trials.

Develop effective Research Coordinator and Research Assistant workflows and systems to assure protocol adherence and data quality.

Serve as point of contact for the study team regarding operational aspects of clinical research, to resolve issues and remove obstacles for study team members.

Oversee subject recruitment and enrollment (eligibility check lists, double-checks).

Review monitoring visit reports and deviation logs prior to sign off and provide leadership in identifying and implementing corrective actions/processes.

Help evaluate priorities for workload and identify opportunities for process improvement.
Data Management, Integrity and Compliance Oversight - 15%

Oversee the data integrity of Breast Cancer Research Program clinical trials.

Understand multiple commercial electronic data capture systems and ensure timely and accurate entry of complex clinical information.

Independently resolve and answer data queries with minimal errors.

Make independent judgments about the relevance of the clinical data to the research for complicated oncology research subjects.

Work with study team members to obtain, abstract, and code complex clinical information from multiple sources (medical records, research records, etc.) for research subjects.

Code and record said information into various study-specific data-capture systems (both electronic and paper-based).

Work with sponsor representatives to review and correct data recorded in the case report forms.

Resolve queries in conjunction with Research Coordinators and Research Assistants.

Provide input in design and implementation of research tools for investigator-initiated trials.

Develop and maintain data standard operating procedures and workflows for the Program.

Interpret, implement and verify compliance with applicable federal and institutional SOPs.

Develop procedures for data quality control to ensure completeness and accuracy of data.
Other Program Support - 5%

Support the Research Manager with hiring, training and onboarding of new research staff.

Collaborate with Research Manager, Regulatory and Clinical Implementation Manager, Regulatory Coordinators and Research Coordinators as needed to support operations of overall research program.

Perform other tasks as assigned.
MINIMUM REQUIREMENTS

Bachelor’s Degree in Biology or Health-related field.

A minimum of 3 years-experience in clinical research project coordination.
Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.
ADDITIONAL REQUIREMENTS

Knowledge of FDA and NIH requirements relating to research involving human subjects.

Experience in clinical trial development.

Implementation and analysis.

Excellent written and verbal communication skills.

Experience with Microsoft Office.

Experience with case report forms (ideally paper and electronic).

The position is located in a clinical and research environment that is located at the Seattle Cancer Care Alliance on the Fred Hutchison Cancer Research Center.

Travel to/from campus buildings is required. Work hours may exceed 40 hours per week and can be deadline dependent.

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 30 days of hire.

Applicants should be highly motivated and energetic and while remaining personable, professional and organized under potentially stressful situations.

Applicant should have the ability to be flexible and adapt to change (e.g. new projects, shifting priorities, emergent deadlines) readily.)
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 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.