Research Coordinator

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 purpose of this position is to promote the research objectives of the Division of Hematology and Oncology. This position works with the Acute Leukemia, MDS/MPN, and Classical Hematology disease group faculty to facilitate investigator-initiated and industry-sponsored clinical trials.

Position Complexities

This position is constantly required to integrate information from multiple sources to ensure that all research proposals meet the requirements of the University, the Food and Drug Administration, the National Institutes of Health, and the study sponsor. This position develops procedures that ensure that all research meets or exceeds these requirements while expeditiously furthering the research objectives of the Division of Hematology and Oncology, the Acute Leukemia, MDS/MPN, and Classical Hematology disease groups. There are multiple resources available within the University system (e.g. Grant and Contract Services, Institutional Review Board, Office of Sponsored Programs) to help in this process, but ultimately, the work must be done independently and in a resourceful manner to expedite the Division's research objectives. This position is also responsible for organizing and facilitating sponsor-initiated, FDA-initiated, and institution-initiated audits of study data. Finally, this position interacts with representatives from federal and state agencies, foundations, pharmaceutical companies, health care providers, and hematology/oncology patients in a manner that well-represents the University of Washington.

Position Dimensions and Impact to the University

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 provides significant contributions to research development, implementation and analysis for the Division of Hematology and Oncology.

DUTIES AND RESPONSIBILITIES

This position must be able to work independently under administrative direction on multiple research projects; at times, without the benefit of written policies or procedures, while concurrently helping to create best practices moving forward. This position requires daily interaction with sponsors, physicians, the U.S. Food and Drug Administration, other health care personnel (e.g. nurses, patient care coordinators, insurance companies), and patients. Up to 15 projects will be in progress simultaneously, with the expectation of additional projects in the future.

Protocol Development and Management, and Regulatory - 40%

Work with multiple UW and Fred Hutchinson Cancer Center (FHCC) groups to ensure timely implementation of each research project.

Use knowledge of clinical research, medical terminology, and clinical processes to interpret complex protocol requirements and identify protocol procedures that will impact clinic operations.

Participate in clinical implementation of research activities at UWMC and FHCC for new studies in start-up and studies with protocol amendments.

Independently develop and implement research project policies and procedures that meet research objectives and 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, create, and revise research instruments (e.g. case report forms) as necessary to ensure quality data that correlates with research objectives.

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

Write informed consent documents that clearly describe the nature and risks of the research project in language that is easily understandable to the individual patient.

Work collaboratively with research team to ensure that projects are executed successfully and completed within required time frames to meet research objectives.

Work with Regulatory Coordinator to ensure that reports to the Institutional Review Board and study sponsors are timely, accurate, and satisfy applicable regulation. With minimal guidance, develop and implement corrective action plans to ensure protocol adherence and data integrity.

Understand clinical trial budget and billing plan for patients enrolled on clinical trials.

Work with internal partners to ensure clinical trials are performed in accordance with institutional requirements for billing compliance. Assist in financial audits.

Communicate with investigators and research staff when financial milestones have been met.

Study Subject Management - 40%

Advise clinical staff which tests and procedures are needed during each research visit to facilitate protocol adherence, billing compliance, and to ensure accurate and reliable data collection. Work closely with clinical providers to ensure that study therapy is administered in accordance with the clinical protocol (e.g. dose modifications are implemented when required by the protocol).

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

Ensure that projects are executed successfully and completed within needed time frames to meet research objectives.

Prepare laboratory and specimen collection kits according to protocol and lab manual instructions. Work with different departments across UW and FHCC to collect, process, and transport specimen samples.

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.

Initiate and maintain communication with outside physicians who refer patients to UWMC and/or FHCC for clinical trials.

Timely and appropriate reporting of Adverse Events and Serious Adverse Events to sponsors and review boards to ensure compliance to protocol and FDA requirements.

Analysis and Reporting - 15%

Prepare interim reports for principal investigators, industry sponsors and Institutional Review Board to ensure that each project is moving toward timely completion.

Prompt completion of electronic data capture systems and electronic case report forms.

Timely resolution of queries and questions from industry sponsors, contract research organizations, institutional groups and our affiliates.

Other/miscellaneous - 5%

Develop training materials and standard operating procedures.

Train and mentor staff.

Other duties as assigned.

MINIMUM REQUIREMENTS

Bachelor's Degree in related field or equivalent experience.

At least two years related work experience.

Previous clinical research experience working with human subjects.

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 HIPAA regulations, GSP and HSD training, and FDA guidelines relating to research involving human subjects.

Strong attention to detail and ability to multi-task, organize, and prioritize projects and competing deadlines.

Excellent written and verbal communication skills.

Strong computer skills and competency with Microsoft Office software.

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.

DESIRED QUALIFICATIONS

Previous experience working in Hematology and/or Oncology.

CCRC or CCRP endorsement.

Experience working within the UW/FHCC setting.

Familiarity with Epic electronic health record system.

CONDITIONS OF EMPLOYMENT

Sitting at desk for majority of hours worked; working on a computer and on the telephone in a cubicle in a public area with little privacy. Ability to multi-task and be flexible while maintaining a professional demeanor is crucial as priorities change throughout each day. May respond to multiple requests for information (e-mail, voicemail, fax, verbal), determining priorities. Flexible work schedule. Stringent deadlines from sponsors and faculty for protocol implementation and data collection may require overtime. Integrating required elements of research into complex patient schedules (e.g collecting and processing multiple blood specimens for pharmacokinetic sampling) may also require occasional overtime.

Must be available to enroll patients and maintain email/pager contact with 24/7 availability. Some evening and weekend travel to study meetings and sites may be required.

This position is located in a clinical research environment at the Fred Hutchinson Cancer Center campus and requires the physical ability to get between offices, clinic, and other facilities, up to 1-mile distance.

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.